Orthopedic device

ABSTRACT

An orthopedic system includes an orthopedic device defining a posterior aspect, an anterior aspect opposite the posterior aspect, and a structure at least in part defining a receiving space arranged to receive an activity tracking device. An activity tracking device is positionable and securable in the receiving space of the orthopedic device. The activity tracking device is arranged to generate information associated with activity level or compliance of a patient wearing the orthopedic device during treatment.

TECHNICAL FIELD

The disclosure relates to an orthopedic device for protecting and/orimmobilizing one or more affected areas on a user's lower leg, ankle,and/or foot.

BACKGROUND

It is common that people, especially frail elderly people and diabetics,experience a variety of lower leg, ankle, and foot injuries. Physicianstraditionally have treated, and still currently treat, injuries such aspressure ulcers affecting the foot by fitting the injured patient withthe well-known, molded plaster or resin cast. The placement of this typeof cast is time consuming, heavy, and costly. Further, this type of castmust not come into contact with water, which makes patient bathingdifficult and time consuming. Additionally, if the cast needs to beremoved for any reason, for example, inspection, a whole new cast mustbe prepared and applied.

Alternatively, walking boots or walkers have been used for protectingand immobilizing injured or affected areas of the lower leg, ankle,and/or foot, such that at least partial mobility may be maintained whilethe affected areas are in the process of healing. Further, in contrastto the molded plaster or resin cast, a walker can be easily removed inorder to bathe or for inspection of the injured limb by a physician orpractitioner.

Existing wrap-around or circumferential walkers however can be bulky anduncomfortable for users. Particularly, hard edges and/or surfaces ofexisting walkers can cause pressure points on the user's toes, feet,ankle, and/or lower leg that can cause users pain and discomfort, andmay also cause injury to a user, such as pressure ulcers. Pressureulcers can become infected, contain scar tissue, and may result insecondary problems up to and including amputation.

Alternatively, existing walkers may include inflatable supports forimproving the comfort of the walker, but these inflatable supports canbe more harmful than helpful. Particularly, existing walkers require theuser to regulate or control the pressure level in the inflatablesupports. This is problematic because patients, especially those withdiabetes, often experience reduced sensation in their extremities, whichcan result in them inadvertently overinflating the inflatable supports.Over-inflation of the inflatable supports can cause pressure on the skinwhich can reduce both capillary blood flow to the skin and arterial flowto the affected limb. It can also lead to the formation of pressureulcers on the foot of the patient and longer healing times for existingulcers. Further, existing walkers with inflatable supports often requirepatients to monitor pressure levels in the inflatable supports with apressure gauge. However, many patients do not see well enough to readthe pressure gauges and such pressure gauges are also known tomalfunction.

Additionally, features associated with the inflatable supports inexisting walkers are known to create pressure points within the walkerand/or to be unreliable. For instance, tubing associated with theinflatable supports is typically routed along the inside surface of thewalker, creating pressure points on the inside of the walker, which canbe uncomfortable and can cause additional pressure ulcers. Moreover,such tubing can become kinked and/or pinched between the walker and thepatient's lower leg, ankle, and/or foot, rendering the inflatablesupports effectively inoperable. Pump features associated with theinflatable supports are also commonly arranged on the walker such thatthey are prone to being bumped, misaligned, and/or damaged during use,increasing the likelihood that the inflatable supports will beinadvertently inflated, deflated, and/or rendered inoperable.

SUMMARY

The orthopedic device described herein may be, in exemplary embodiments,a lightweight walker. It is also contemplated that other orthopedicdevices may utilize similar configurations as described below.

The orthopedic device described herein typically takes the form of asemi-rigid or substantially rigid shell walker, which providesprotection and immobilization to an affected area on the lower leg,ankle, and/or foot by surrounding the lower leg, ankle, and/or foot withan appropriate structure. It will be recognized that the featuresdescribed herein may have applicability to other walker configurationsor other types of orthopedic devices.

In the exemplary embodiments, various configurations of flexible edgearrangements, inflation system arrangements, and shell arrangements areutilized to limit pressure points and/or excessive pressure on a user'slower leg, ankle, and/or foot in order to provide a more comfortable fitand more effective treatment of affected areas on the user's lower leg,ankle, and/or foot.

For example, an orthopedic device may include a base shell having ankleand foot receiving portions and forming an opening over a dorsal aspectof the base shell. A dorsal shell can be contoured to generallycorrespond to the opening in the base shell. The dorsal shell caninclude a proximal member connected to a distal member via a flexible orresilient connecting portion arranged to accommodate a portion of theuser's lower leg or ankle.

A first flexible edge portion can be attached to a distal terminal endof the distal member. During use, the distal member of the dorsal shellcan become pitched or angled relative to the user's toes due to avariety of different circumstances, including, but not limited to, useranatomy, use of heel lifts and/or wedges, or as the user walks. Thefirst flexible edge portion can be arranged to flex or bend relative tothe distal member when the distal member pitches or angles relative tothe toes. This has the effect of reducing the transfer of force from thedistal member to the toes and/or distributing the force from the distalmember over a greater surface area, which, in turn, reduces thelikelihood of a potentially harmful pressure point on the user's toesfrom the distal member.

The first flexible edge portion can also help accommodate bandaging ofthe user's toes or the forefoot because the first flexible edge portioncan be flexed upward or removed from the distal member. The firstflexible edge portion can also include a toe relief portion radiallyextending away from the user's toes, substantially reducing thelikelihood of the distal member diving down into the toes, which couldcause discomfort or even injury.

The proximal member of the dorsal shell may also include a secondflexible edge portion attached to a proximal terminal end of theproximal member. The second flexible edge portion on the proximal membercan be arranged to bend or flex when the user's leg exerts a force onthe second flexible edge portion. This has the effect of reducing thelikelihood of creating a pressure point on the user's lower leg from thedorsal shell and can provide pressure relief to the user's tibia,improving the comfort and effectiveness of the orthopedic device.

At least one observation hole may be formed in the base shell posteriorof the user's malleoli to allow for tactile confirmation of the positionof the user's foot within the orthopedic device, which can reduce thelikelihood of one or more pressure points within the orthopedic devicefrom the user's heel being too far back within the base shell.

By way of another example, an orthopedic device may include a base shelland a dorsal shell contoured to generally correspond to an opening inthe base shell. At least one tightening member can be connectable to thebase shell and extendable over the dorsal shell to secure the base shelland dorsal shell together about a user's lower leg and foot. At leastone inflatable bladder may be provided in the base shell and a pumpassembly may be arranged to inflate the at least one inflatable bladder.

The pump assembly can be situated on the at least one tightening membersuch that the position of the pump assembly is substantially fixedrelative to the base shell as the user walks in the orthopedic device.This advantageously limits unwanted movement of the pump assembly,reducing the likelihood of the pump assembly inadvertently inflating ordeflating the at least one inflatable bladder as in the prior art. Thepump assembly may also be situated on an anterior aspect of the at leastone tightening member, increasing the usability of the pump assembly.

The base shell can include at least one tube hole formed therein thatallows at least one inflation tube to pass from the pump assembly to anexterior surface of the base shell such that the at least one inflationtube can run along the exterior surface of the base shell rather thanthe interior of the base shell as in the prior art. This has the effectof reducing the likelihood of a pressure point from the at least oneinflation tube as the user walks in the orthopedic device and thelikelihood of the at least one inflation tube being pinched or kinkedinside of the orthopedic device.

A pressure relief valve assembly can be fluidly connected to the atleast one inflatable bladder and arranged to automatically release airfrom the at least one inflatable bladder to atmosphere when pressurewithin the at least one inflatable bladder exceeds a cracking pressureof the pressure relief valve assembly. This allows the pressure reliefvalve to automatically regulate or limit the pressure level within theat least one inflatable bladder rather than requiring the user toregulate the pressure level, as in the prior art, eliminating orsubstantially decreasing the likelihood that a user will over-inflatethe at least one inflatable bladder. This is advantageous because usersof walkers and other orthopedic devices, especially diabetic patients,often experience reduced sensation in their extremities, which canresult in them inadvertently over-inflating the at least one inflatablebladder. Such over-inflation can cause pressure on the skin, which canreduce both capillary blood flow to the skin and arterial flow to theanatomical member. It can also lead to the formation of pressure ulcerson the foot of the patient and longer healing times for existing ulcers.

Further, because the pressure relief valve automatically regulatespressure within the at least one inflatable bladder, users can inflatethe at least one inflatable bladder without the need of reading apressure gauge as in the prior art, making the orthopedic device easierand safer to use. The pressure relief valve assembly also overcomesissues with changes in ambient pressure creating excessive pressurewithin the at least one inflatable bladder, such as a change inaltitude, as the pressure relief valve assembly automatically reducesexcess pressure in the at least one inflatable bladder.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features, aspects, and advantages of the presentdisclosure will become better understood regarding the followingdescription, appended claims, and accompanying drawings.

FIG. 1 is a front side isometric view of an orthopedic device comprisinga walker according to an embodiment.

FIG. 2 is a back side isometric view of the walker shown in FIG. 1.

FIG. 3 is a detail view of an eyelet shown in FIG. 2 according to anembodiment.

FIG. 4 is a front isometric view of a hook tab component according to anembodiment.

FIG. 5 is a back isometric view of the hook tab component shown in FIG.4.

FIG. 6 is a back isometric view of the hook tab component and atightening tool according to another embodiment.

FIG. 7 is a front side isometric view of the base shell shown in FIG. 1.

FIG. 8A is a front side isometric view of the dorsal shell shown in FIG.1.

FIG. 8B is a partial front side isometric view of the dorsal shell shownin FIG. 8A.

FIG. 9 is a back side isometric view of the dorsal shell shown in FIG.1.

FIG. 10 is a front isometric view of a walker according to anotherembodiment.

FIG. 11 is a front isometric view of a compliance clasp assembly in aclosed position according to another embodiment.

FIG. 12 is a partial front isometric view of a compliance clasp in anopen position according to an embodiment.

FIG. 13 is a sectional view of the compliance clasp shown in FIG. 12taken along section line 12-12.

FIG. 14 is a front isometric view of a compliance clasp in an openposition according to another embodiment.

FIG. 15 is a front isometric view of a walker according to anotherembodiment.

FIG. 16 is a back isometric view of the walker shown in FIG. 15.

FIG. 17 is a schematic view of an air inflation system for use with thewalker shown in FIG. 15 according to an embodiment.

FIG. 18 is an exploded view of a pump assembly according to anembodiment.

FIG. 19 is an exploded view of a pump assembly according to anotherembodiment.

FIG. 20 is a partial side view of the walker shown in FIG. 15.

FIG. 21 is a partial exploded back view of the walker shown in FIG. 15.

FIG. 22 is a side isometric view of the pressure relief valve assemblyshown in FIG. 21.

FIG. 23 is a cross sectional view of the pressure relief valve assemblyshown in FIG. 22.

FIG. 24 is a side isometric view of a pressure relief valve assemblyaccording to another embodiment.

FIG. 25 is a cross sectional view of the pressure relief valve assemblyshown in FIG. 24.

FIG. 26 is an isometric view of a pressure relief valve assembly andcover member according to another embodiment.

FIG. 27 is a front view of the base shell shown in FIG. 15 with theliner removed, showing the bladder.

FIG. 28 is a schematic diagram of an inflation system according toanother embodiment.

FIG. 29 is a front isometric view of an orthopedic system according toanother embodiment.

FIG. 30 is a schematic diagram of the orthopedic device in FIG. 29positioned on a knee scooter.

FIG. 31 is a back isometric view of the protective part in FIG. 29removed from the orthopedic device for ease of reference.

FIG. 32 is a front isometric view of an orthopedic system according toanother embodiment.

FIG. 33 is a front isometric view of an orthopedic system according toanother embodiment.

FIG. 34 is a front isometric view of an orthopedic system according toanother embodiment.

FIG. 35 is a back isometric view of the protective part in FIG. 34removed from the dorsal shell for ease of reference.

FIG. 36 is a back isometric view of the dorsal shell in FIG. 34.

FIG. 37 is a side isometric view of an orthopedic system according toanother embodiment.

FIG. 38 is a partial exploded view of the orthopedic device andstabilizing part in FIG. 37.

FIG. 39 is a top view of the stabilizing part in FIG. 37.

FIG. 40 is a back view of the stabilizing part in FIG. 37.

FIG. 41 is a side view of the stabilizing part in FIG. 37.

FIG. 42 is a top view of a stabilizing part according to anotherembodiment.

FIG. 43 is a back isometric view of an orthopedic system according toanother embodiment.

FIG. 44 is a front view of the inside of the orthopedic device in FIG.43.

FIG. 45 is a front view of the cover member and activity tracking devicein FIG. 43 removed from the orthopedic device for ease of reference.

FIG. 46 is an architectural schematic diagram of a monitoring systemaccording to an embodiment.

FIG. 47 is a back view of an orthopedic system according to anotherembodiment.

FIG. 48 is a front view of an orthopedic system according to anotherembodiment.

DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS

A better understanding of different embodiments of the disclosure may behad from the following description read with the accompanying drawingsin which like reference characters refer to like elements.

While the disclosure is susceptible to various modifications andalternative constructions, certain illustrative embodiments are in thedrawings and described below. It should be understood, however, there isno intention to limit the disclosure to the embodiments disclosed, buton the contrary, that the intention covers all modifications,alternative constructions, combinations, and equivalents falling withthe spirit and scope of the disclosure.

For further ease of understanding the embodiments of an orthopedicdevice as disclosed herein, a description of a few terms is necessary.As used herein, the term “dorsal” has its ordinary meaning and refers tothe top surfaces of the foot, ankle and foreleg or shin. As used herein,the term “plantar” has its ordinary meaning and refers to a bottomsurface, such as the bottom of a foot. As used herein, the term“proximal” has its ordinary meaning and refers to a location that iscloser to the heart than another location. Likewise, the term “distal”has its ordinary meaning and refers to a location that is further fromthe heart than another location. The term “posterior” also has itsordinary meaning and refers to a location that is behind or to the rearof another location. Lastly, the term “anterior” has its ordinarymeaning and refers to a location that is ahead of or to the front ofanother location.

The terms “rigid,” “flexible,” and “resilient” may be used herein todistinguish characteristics of portions of certain features of theorthopedic device. The term “rigid” is intended to denote that anelement of the device is generally devoid of flexibility. Within thecontext of support members or shells that are “rigid,” it is intended toindicate that they do not lose their overall shape when force isapplied, and in fact they may break if bent with sufficient force. Onthe other hand, the term “flexible” is intended to denote that featuresare capable of repeated bending such that the features may be bent intoretained shapes or the features do not retain a general shape, butcontinuously deform when force is applied. The term “resilient” is usedto qualify such flexible features as generally returning to an initialgeneral shape without permanent deformation. As for the term“semi-rigid,” this term is used to connote properties of support membersor shells that provide support and are free-standing; however suchsupport members or shells may have some degree of flexibility orresiliency.

An exemplary embodiment of a walker 100 is shown in FIGS. 1-9. As can beseen from the figures this embodiment includes complementary base 102and dorsal 104 shells that are selectively engageable with each other inorder to provide easy access to the interior of the device for ease ofdonning and doffing the device, in particular for donning and doffingthe device unto an injured limb. The base shell 102 has ankle and footreceiving portions 101, 103 (best shown in FIG. 7) and forms an opening105 (best shown in FIG. 7) over a dorsal aspect thereof. The dorsalshell 104 is contoured to generally correspond to the opening 105 of thebase shell 102.

The walker 100 can include a semi-rigid or substantially rigid shellconfiguration that is formed to support and support the lower leg, foot,and ankle of the user or patient. The shell configuration can extendfrom the foot and ankle up along the shin and tibia of the lower leg toa desired point below the knee joint. Exemplary suitable materials forforming the shells can include metals, such as aluminum, carbon,composites, glass fiber/epoxy composites, or suitable plastic materials,such as thermoplastic or thermosetting polymers, fiber reinforcedplastic, molded chopped fibers, or any other suitable material. Otherexemplary materials include, but are not limited to, nylons, glassfilled nylon, polypropylenes, vinyls, polyvinyl chlorides, high densitypolyethylene, epoxies, urethanes, and polyesters. While the walker isdescribed having a rigid shell configuration, it will be appreciatedthat the walker 100 may be any type of walker or other suitableorthopedic device.

In use, a user can move the walker 100 from a closed configuration to anopen configuration by moving the dorsal shell 104 away from the baseshell 102, allowing insertion of the lower leg, ankle, and foot into thewalker 100. Once the user has inserted their lower leg into the walker100, the dorsal shell 104 can be returned to the closed configuration toenclose the lower leg within the walker 100. The user can then utilizeone or more tightening mechanisms described below to apply pressure andsupport and to maintain the walker 100 in the closed configuration.

The walker 100 can be oversized to accommodate a number of differentaccessory components and/or sized feet. A width of the walker 100 can bedefined between the lateral and medial sides of the walker 100. Thewidth of the walker 100 can be between about 1.02 and about 1.5, betweenabout 1.05 and about 1.3 (e.g., about 1.08), or between about 1.1 andabout 1.2 times greater than the width of a conventional walker. Forinstance, if a conventional walker has a width of about 140 mm, thewalker 100 can have a width between about 145 mm and about 160 mm (e.g.,about 152 mm). This has the effect of providing a larger foot bed withinthe walker 100 for insertion of accessory components, such as, but notlimited to, heel wedges, inflatable bladders, padding, or other suitablecomponents. This also allows the walker 100 to accommodate larger feetand/or to be a multi-purpose walker. For instance, the oversized footbed can provide sufficient space to add and/or remove components fromthe walker 100, allowing the walker 100 to be customized for a specificpurpose. More particularly, by adding and/or removing components fromthe foot bed of the walker 100, the walker 100 can be converted from onetype of walker to another type of walker (e.g., from a diabetic walkerto an Achilles walker, or a fracture walker, or vice versa).

The shell configuration includes a base shell 102 and a dorsal shell104. At least one of the base shell 102 or the dorsal shell 104 can havegenerally smooth rounded edges, helping to increase the comfort andsafety of the walker 100. The base shell 102 has a posterior portion 106(best shown in FIG. 2) and a plantar portion 108 that is arranged toextend along the plantar surface of the foot. Lateral and medial (firstand second) wing portions 110 extend from the posterior portion 106 andthe plantar portion 108. The wing portions 110 can be arranged to atleast partially enclose and support a user's leg. A soft good liner 112can be situated inside the base shell 102. An insole 114 can be providedon the proximal surface of the liner 112 and/or the base shell 102. Anoutsole 116 is formed on the base shell 102, either integrally, orseparately. The outsole 116 can define a toe protector portion 118 andcan have any suitable configuration, such as a rubber sole having a rollover shape.

In order to reduce the weight of the walker 100 and/or to provideventilation, material can be removed from areas of the shell portions toprovide apertures 120. The apertures 120 can be formed in any of theshells 102, 104. The apertures 120 can have different sizes and/orshapes. The apertures 120 can extend at an angle. For instance, some ofall of the apertures 120 can have a generally oblong shape and canextend at an angle. The apertures 120 in the ankle region of the baseshell 102 can be longer than the apertures 120 in a toe region of thebase shell 102.

Some or all of the apertures 120 can be arranged in one or moregradients. Arranging the apertures 120 in gradients can improve thebiomechanical properties of the shells with respect to an anatomicallimb positioned in the walker 100 by influencing the flexibility orstiffness of the shells with the apertures. For instance, the apertures120 in the foot receiving portion 103 of the base shell 102 can bearranged in a gradient with larger apertures 120 in the ankle region andsmaller apertures in the toe region. The apertures 120 in an upperregion of the base shell 102 can be arranged with larger apertures 120toward the middle of the lower leg and smaller apertures 120 toward theankle and the knee.

In other embodiments, the apertures 120 in the upper region of the baseshell 102 can have different sizes and shapes and can be extending at anangle. Some or all of the apertures 120 can also be arranged in aplurality of rows. Some or all of the apertures 120 in the footreceiving portion 103 of the base shell 120 can comprise a series ofslots extending at an angle and a singular larger, irregularly shapednon-through hole in the toe region.

The apertures 120 can comprise through holes and/or non-through holes.Some or all of the apertures 120 in the foot receiving portion 103 ofthe base shell 102 can be non-through holes. This can prevent ingress ofexternal objects through the apertures 120 that may potentially injurethe foot, which, in turn, enhances user safety. This also has the effectof protecting the user's foot from sharp edges that can injure the foot.The non-through holes in the foot receiving portion 103 are especiallyimportant for users of the walker 100 who suffer from neuropathy havingnerve damage in the foot. Non-through holes in either shell can alsoreinforce or strength the walker 100 in the region of the apertures 120.

Some or all of the apertures 120 can comprise through holes. Some or allof the through holes can be positioned, shaped, sized, and/or patternedto enhance heat and/or fluid transfer from the interior of the walker100 to the exterior of the walker 100. This can allow the walker 100 tovent heat and/or perspiration from the interior of the walker 100,which, in turn, increases user comfort. The through-holes can alsoprovide some level of resiliency to the shells. This can allow thewalker 100 to better accommodate swelling of a limb or different sizesof lower legs, ankles, and/or feet.

Some or all of the apertures 120 can include a through-hole portion anda non-through hole portion. For instance, some or all of the apertures120 can include a periphery and upstanding sidewall portions extendingabout the periphery. A non-through hole portion can include a bottomsurface formed by a portion of the shell and a through-hole portion canbe open ended, extending completely through the shell.

Some or all of the apertures 120 can include radiused or rounded-offedges, reducing the likelihood of a user inadvertently scrapping orinjuring a non-affected limb on the edges of the apertures 120 as thenon-affected limb moves back and forth across the apertures.

The walker 100 can have structures designed to selectively strengthenthe base shell 102 and the dorsal shell 104 in a specific direction. Thebase shell 102 can include reinforcing ridges 121 that extend at anangle along both lateral and medial sides thereof.

As can be seen in FIGS. 1 and 2, eyelets 122 can be formed in the wingportions 110 of the base shell 102 for providing one or more anchoringpoints for different components and/or accessories. FIG. 3 is a detailedview of an eyelet 122 according to an embodiment.

The eyelet 122 can include an annular rim portion 124, a sloping innersidewall portion 126, a through-hole portion 128, and a seat 130 formedin the inner sidewall portion 126 for receiving and securing a portionof an attachment system (e.g., a hook portion) therein. The eyelets 122can be at least partially debossed below an exterior surface of the baseshell 102 such that each eyelet 122 is at substantially the same depthbelow the exterior surface.

Some or all of the eyelets 122 can provide an anchoring a point for ahook tab component, such as the hook tab component 132 shown in FIGS. 4and 5. As seen, the hook tab component 132 can comprise a largergenerally elliptical main body 134, a smaller portion 136, a generallyplanar bottom side 138, and an upper side 140. The hook tab component132 can be formed from any suitable material such a plastic, rubber, ormetal material.

The bottom side 138 of the hook tab component 132 can arranged toprovide an attachment surface for a portion of a hook-and-loop typesystem (e.g., Velcro®), the liner 112, a pad, an inflatable bladderdescribed below, or any other suitable component. The attachment surfacecan be used to place an adhesive dot or two sided tape on the hook tabcomponent 132. For instance, a pad could be adhered to the bottom side138 of the hook tab component 132 via the adhesive dot or two sided tapeand then secured in a fixed position on the walker 100 as desired.

A hook member 142 can be formed on the upper side 140 for interfacingwith an eyelet 122. The hook member 142 can exhibit any suitableconfiguration. The hook member 142 can include a generally rectangularbase portion attached to the upper side 140 and a generally oblong headportion attached to the rectangular base portion.

The hook member 142 can anchor the hook tab component 132 to the baseshell 102. The hook tab component 132 can be situated inside the walker(shown in FIG. 7) and the head portion of the hook member 142 can begenerally aligned with the through-hole portion 128 in the eyelet 122.The head portion of the hook member 142 can then be inserted through thethrough-hole portion 128 and rotated until the head portion of the hookmember 142 rests in the seat 130 of the eyelet 122, which secures thehook tab component 132 within the eyelet 122. While secured in theeyelet 122, the upper side 140 of the hook tab component 132 can befacing and/or secured against the interior surface of the base shell102. This allows the location of components inside of the walker 100 tobe customized by installing hook tab components 132 attached orattachable to the components in different eyelets 122 formed in the baseshell 102.

Optionally, the hook tab component 132 can include installation featuresto aid in the installation of the hook tab component in the eyelet 122.FIG. 6 illustrates a hook tab component 232 according to anotherembodiment including a recessed portion 244 formed in the bottom side238 of the smaller portion 236.

A user can insert a tightening tool 246 or key within the recessedportion 244 to rotate the hook tab component 232 within the eyelet 122relative to the base shell 102. A first portion of the tightening tool246 can be positioned on the bottom side 238 at or near a center of thehook tab component 232. A protrusion 247 on the tightening tool 246 canbe positioned in the recessed portion 244. The tightening tool 246 canthen be rotated about the first portion on the center of the hook tabcomponent 232, which, in turn, causes the protrusion to engage ashoulder formed by the recessed portion 244, rotating the hook tabcomponent 232. This can facilitate installation of the hook tabcomponent 232 in the eyelet 122. Requiring the use of the tighteningtool 246 can help deter a patient or user from removing or moving thehook tab components 232, and thereby components attached thereto, fromthe walker 100 without the consent of a clinician or medicalprofessional. The tightening tool 246 can also be provided to theclinician or medical professional but not the user or patient, helpingto prevent tampering.

Referring again to FIG. 2, a flexible or resilient edge portion 148 andexpansion joints 150 can be formed on the posterior portion 106 of thebase shell 102 along the edges of and between the posterior of the wingportions 110. The expansion joints 150 can be arranged in discretegroupings and formed having a larger dimension at the proximal end andtapering down to a smaller dimension at the distal end. The expansionjoints 150 can include any number of expansion holes 151 passingtherethrough. The expansion holes 151 can be arranged in any suitablemanner and can have any desired shape or size.

Some or all of the expansion joints 150 and/or the flexible edge portion148 can be formed via overmolding a different material onto end portionsof the base shell 102. For instance, the flexible edge portion 148 canbe formed via a flexible plastic or elastomer, such as, for example,thermoplastic elastomer (TPE), rubber, or ethylene vinyl acetate (EVA)foam. In other embodiments, any other suitable material may be utilized,including silicone or natural or synthetic fibers. Overmolds andovermolding techniques are described in more detail in U.S. Pat. No.5,951,504, granted Sep. 14, 1999, U.S. Pat. No. 7,018,351, granted Mar.28, 2006, U.S. Pat. No. 7,288,076, granted Oct. 30, 2007, U.S. Pat. No.7,311,686, granted Dec. 25, 2007, and U.S. Pat. No. 8,002,724, grantedAug. 23, 2011, all of which are incorporated herein, in their entirety,by this reference.

One or more observation holes 152 are formed in the wing portions 110 ofthe base shell 102 in the ankle receiving portion 101, allowing for easyobservation of the position of the user's foot within the walker 100and/or observation of the operation of one or more inflatable bladderswithin the walker 100. The observation holes 152 can exhibit anysuitable configuration. The observation holes 152 can comprise generallyrounded triangular through-holes positioned posterior to the malleoli inthe base shell 102. The position, size and shape of the observationholes 152 can be arranged for tactile confirmation of the position ofthe foot within the walker 100. Using the observation holes 152 aclinician, medical professional, or user can confirm that the heel ofthe user is properly positioned within the walker 100, which, in turn,reduces the likelihood of pressure points within the walker 100 from theheel being too far back.

Wounds in the ankle region of the user's foot can be observed via theobservation holes 152 without the need of removing the walker 100 fromthe foot, increasing the convenience of the walker 100. The observationholes 152 can also allow for tactile and/or visual confirmation thatinflatable bladders positionable inside the base shell 102 are properlyinflating or inflated, decreasing the likelihood of improper inflation.

While the observation holes 152 are described as generally triangular,it will be appreciated that the observation holes 152 can be generallycircular, generally oval, generally diamond, or any other suitableshape. Further, while two observation holes are shown, in otherembodiments, the walker 100 can include one, three, four, or any othersuitable number of observation holes. The observation holes 152 can alsobe formed in any portion of the walker 100.

As best seen in FIGS. 1, 2 and 7, a plurality of tightening mechanisms154 can be arranged to bring the base shell 102 and the dorsal shell 104closer together for tightening the walker 100 around the lower leg,ankle, and the foot. The plurality of tightening mechanisms 154 caninclude an ankle strap 154A, an upper strap 154B, and a foot strap 154C.

The ankle strap 154A can be arranged to cross over the ankle and tosubstantially fix the position of the ankle relative to the walker 100.The upper strap 154B can be arranged to cross over the lower leg belowthe knee. The upper strap 154B in concert with the ankle strap 154A cansubstantially fix the position of the lower leg relative to the baseshell 102 by forming at least two anchoring points, one over the ankleand the other below the knee. The foot strap 154C can be arranged tocross over the dorsal aspect of the foot. The foot strap 154C in concertwith the ankle strap 154A can substantially fix the position of the footrelative to the base shell 102 by forming at least two anchoring points,one over the ankle and one over the distal aspect of the foot. Thearrangement of the straps 154 help to keep the foot and/or ankle frommoving around in the foot bed of the walker 100 reduces the likelihoodof sores forming on the plantar surface of the foot, ankle, and/or lowerleg from unwanted movement of the same within the walker 100.

The straps 154 can comprise any suitable material. The straps 154 caninclude woven materials, cotton, foam, rubber, nylon, polyesters,neoprene, vinyl, webbing, or any other suitable material. The straps 154can include any suitable type of fastening system. The straps 154 caninclude corresponding hook-and-loop fasteners so that at least an endportion of the straps 154 can connect a strap 154 to itself. A loop orD-ring can be attached to one end portion of the strap 154, allowing thestrap 154 to be looped through the loop or D-ring and attaching toitself via any suitable fastener.

A plurality of strap slots 156 can be formed in the wing portions 110and the posterior portion 106 of the base shell 102 for receiving andpositioning the straps. Strap connecting portions 158 can be provided onthe wing portions 110 for anchoring the straps 154 on the base shell102. The strap connecting portions 158 can comprise reduced thicknessportions, holes for rivet connections, or other suitable structure. Ifholes or rivet connections are used, connections points for the straps154 can be pivotable. For instance, an end portion of some or all of thestraps 154 can include one or more grommets arranged to receive one ormore rivets, forming a riveted connection between the strap and the baseshell 102, allowing the strap to rotate at least some degree relative tothe base shell 102.

A loop or D-ring 160 can be attached to one end of the upper strap 154B.The upper strap 154B can be threaded through the strap slots 156 on thewing portions 110 of the base shell 102 and the strap slots 156 on theposterior portion 106 of the base shell 102. The upper strap 154B canthen be looped through the loop or D-ring 160 and attached to itself,securing the upper strap 154B over the dorsal shell 104.

Loops or D-rings 160 are attached via loops of fabric that are attachedto the strap connecting portions 158 on one of the wing portions 110 inthe foot receiving portion 103 via loops of fabric. Each of the anklestrap 154A and the foot strap 154C can be connected at one end to thestrap connecting portions 158 on the opposite wing portion 110. Tofasten the ankle strap 154A and the foot strap 154C over the dorsalshell 104, the straps 154A, 154C can be extended across the dorsal shell104 and free ends thereof can be looped through the loops or b-rings 160on the opposite wing portion 110. Each of the ankle strap 154A and thefoot strap 154C can then be connected to itself via any suitablefastener, such as hook-and-loop fasteners. Alternatively, the loops orD-rings in the foot and/or ankle region can be omitted. For instance,the ankle strap 154A and the foot strap 154C can be attached to the wingportions 110 via strap slots formed in the wing portions 110.

Strap slots 156 can be formed medial and lateral of the foot receivingportion 103 in the base shell 102. The foot strap 154C and theconnection of the loop or D-ring 160 in this region pass from the strapconnecting portions 158 on the interior of the base shell 102 throughthese strap slots 156 to the exterior of the base shell 102, situatingthe foot strap 154C on the outside of the base shell 102. The foot strap154C can thus be accessible on the exterior of the base shell 102 ratherthan the interior of the base shell 102, as in the prior art. Thisallows a user to more easily locate and/or thread the foot strap 154Cthrough the loop or D-ring 160 and reduces the likelihood of the footstrap 154C failing inside of the walker 100, making the walker 100easier to don and doff. Further because the foot strap 154C is on theoutside of the base shell 102, the likelihood of pressure points formingalong the dorsal surface of the user's foot from the foot strap 154C issignificantly reduced, making the walker 100 safer and more comfortableto wear.

The number and configuration of the straps 154 is to be regarded asexemplary only, as any suitable number and/or configuration oftightening mechanisms is possible. For instance, the walker 100 caninclude two, four, or any other suitable number of straps. In place ofstraps, other suitable tightening mechanisms, such as buckles or quickconnecting strap mechanisms can be utilized.

Referring to FIGS. 8A-9, the dorsal shell 104 can be formed either in asingle piece or in multiple portions. The dorsal shell 104 can include aproximal member 162 and a distal member 164 connected to the proximalmember 162 via a flexible or resilient connecting portion 166. Aplurality of apertures 120 are formed in the distal member 164 of thedorsal shell 104. The apertures 120 can be slanted and can include agenerally oblong periphery. The apertures 120 can be arranged in a firstcolumn on one side of a longitudinal axis of the distal member 164 and asecond column on the opposite side of the longitudinal axis. Some or allof the apertures 120 can have rounded or curved edges, protecting anunaffected limb from being scratched or cut by the edges of theapertures 120.

Some or all of the apertures 120 in the distal member 164 can benon-through holes, preventing ingress of external objects (e.g., debris,gravel, sand) through the apertures 120 that could injure the foot ofthe user. The non-through holes can further help protect the foot fromsharp edges and/or objects. It will be appreciated that some or all ofthe apertures 120 in the distal member 164 can be through-holes oromitted.

A flexible edge or flexible toe portion 168 can be attached to a distalterminal end of the distal member 164 for reducing the likelihood ofpressure points from the dorsal shell 104 in the toe region of theuser's foot. The flexible toe portion 168 extends between the medial andlateral sides of the distal member 164. The flexible toe portion 168 caninclude a periphery, an upper surface area, a distal sidewall portion,and a proximal sidewall portion extending from the upper surface area.The flexible toe portion 168 can be formed of any suitable material. Theflexible toe portion 168 can be formed of a flexible plastic orelastomer, such as for example, rubber or EVA foam. Other suitablematerials may include silicone or natural or synthetic fibers.

During use, the dorsal shell 104 can become pitched or angled relativeto the user's toes, forcing the distal member 164 and the flexible toeportion 168 onto the toes. The distal member 164 can become pitched orangled relative to the toes due to a variety of different circumstances.For instance, the distal member 164 can become pitched or angledrelative to the toes by user anatomy (e.g., high instep) or with the useof heel lifts and/or wedges. By way of another example, the distalmember 164 can become pitched or angled relative to the toes as the userwalks.

As the distal member 164 pitches or angles relative to the user's toes,the flexible toe portion 168 can bend or flex relative to the distalmember 164. This has the effect of reducing the transfer of force fromthe distal member 164 to the toes and/or distributing the force from thedistal member 164 over a greater surface area, which, in turn, reducesthe likelihood of pressure points forming on the toes from the distalmember 164. The flexible toe portion 168 can also help accommodatebandaging of the toes or the forefoot because the flexible edge portioncan be flexed upwards, cut, and/or removed from the distal member 164.The arrangement of the flexible toe portion 168 also provides a barrierover the toes, protecting the toes from external objects and/or sharpedges.

Optionally, a toe relief portion 170 of the flexible toe portion 168 canangle, curve upward, and/or radially extend away from the user's toes,spacing the toe relief portion 170 a distance away from the toes and/orcreating an axis other than the toe relief portion 170 about which theflexible toe portion 168 can flex. This has the effect of reducing thelikelihood of pressure points on the user's toes from the flexible toeportion 168. In addition, if the flexible toe portion 168 is forceddownward onto the toe protector portion 118 (shown in FIG. 1) of theoutsole 116, the upward angle of the toe relief portion 170 can allowthe flexible toe portion 168 to move up and away from the user's toesrather than diving down into the toes, which could cause discomfort oreven injury. The toe relief portion 170 can bend back away from the toesand toward an upper surface of the distal member 164. The upward angleof the edge portion 168 also can help create additional space toaccommodate the user's toes.

The flexible toe portion 168 can be attached to the distal member 164 ofthe dorsal shell 104 in any suitable manner. The flexible toe portion168 can be overmolded on a distal edge of the distal member 164 withalternating and/or intermeshing portions of the flexible toe portion 168and distal member 164 mechanically fastening the flexible toe portion168 and the distal member 164.

As best seen in FIG. 8B, a ridge portion 172 can be formed on an uppersurface of the distal member 164 for increasing the attachment strengthbetween the flexible toe portion 168 and the distal member 164. Theridge portion 172 can extend at least in part between the lateral andmedial sides of the distal member 164 adjacent the flexible toe portion168. The ridge portion 172 can be elongated, having a proximal sidewallportion, a distal sidewall portion, and an upper surface area extendingbetween the proximal and distal sidewall portions. The ridge portion 172can increase the attachment surface area between distal member 164 andthe flexible toe portion 168.

The flexible toe portion 168 can be attached to both the distal sidewallportion and the upper surface area of the ridge portion 172, increasingthe connection surface area between the distal member 164 and theflexible toe portion 168, which, in turn, increases the connectionstrength between the flexible toe portion 168 and the distal member 164.

The distal sidewall portion of the ridge portion 172 can physicallyblock the foot strap 154C (shown in FIG. 1) from sliding onto theflexible toe portion 168, increasing the protection of the user's toes.The ridge portion 172 preventing or limiting movement of the foot strap154C can also reduce the likelihood of the dorsal shell 104 beingprematurely worn down by a migrating foot strap 154C. The ridge portion172 further can reinforce the flexible toe portion 168. For instance, ifthe flexible toe portion 168 is forced into the toe protector portion118 (shown in FIG. 1) of the outsole 116, the distal sidewall portion ofthe ridge portion 172 can support the proximal sidewall portion of theflexible toe portion 168 against shear or other forces that couldpotentially cause the flexible toe portion 168 to tear away from thedistal member 164 of the dorsal shell 104. In other embodiments, theflexible toe portion 168 can be omitted.

Similar to the flexible edge portion, the connecting portion 166 betweenthe distal member 164 and the proximal member 162 can be arranged toflex or bend. The connecting portion 166 can flex or bend between theproximal member 162 and the distal member 164 as the proximal member 162and/or the distal member 164 move toward and/or away from one another.The proximal member 162 and the distal member 164 can be forced towardone another as the user walks or due to user anatomy or with the user ofheel lifts and/or wedges in the foot bed of the walker 100, or underother conditions.

By flexing between the proximal member 162 and the distal member 164,the connecting portion 166 can help reduce or eliminate the formation ofpressure points along the dorsal surface of a user's lower leg, ankle,or foot from the dorsal shell 104. Further, due to the flexible natureor resiliency of the connection portion 166, when the dorsal shell 104is closed around the user's lower leg, ankle or foot, different sizedanatomies can be accommodated using the same sized walker 100. Inaddition, the connecting portion 166 can help the dorsal shell 104automatically expand or contract due to swelling or reduction ofswelling in the lower leg, ankle, and foot of a user.

The connecting portion 166 can include a periphery, an upper generallycontinuous surface area and a pair of laterally upstanding, sidewallportions extending along two opposed sides of the upper surface area.The connecting portion 166 can further include a distal sidewall portionextending along an edge of the upper surface area and a proximalsidewall portion extending along an edge of the upper surface area. Theproximal sidewall portion can extend along an imaginary curved line thatdefines a peak near a center of the connecting portion 166.

As best seen in FIG. 9, the connecting portion 166 further includes alower generally continuous surface area opposed the upper surface area.At least a portion of the lower surface area can have a concavecurvature to help the connecting portion 166 fit over the ridge of thefoot and/or the ankle. The concave curvature of the connecting portion166 can allow the connecting portion 166 to be more comfortably arrangedalong the dorsal surface of the ankle and/or the foot of a user. Athickness defined between the upper and lower surface areas of theconnecting portion 166 can be arranged to provide cushioning and/orprotection to the ankle and/or foot.

The connecting portion 166 can be attached between the proximal member162 and the distal member 164 in any suitable manner. The connectingportion 166 may be formed via overmolding as discussed above. Theconnecting portion 166 can overlap a portion of the upper surface areasof the proximal member 162 and the distal member 164, increasing theconnection surface area between the connecting portion 166, the proximalmember 162, and the distal member 164.

Referring again to FIG. 8B, a ridge 174 is formed on the upper surfacearea of the proximal member 162 near a distal edge of the proximalmember 162. A ridge 176 is formed on the upper surface of the distalmember 164 near a proximal edge of the distal member 164. The connectingportion 166 extends between the ridge 174 and the ridge 176.

The ridge portion 174 can include an upper surface area, a distalsidewall surface attached to the connecting portion 166 and a generalshape that corresponds to the proximal sidewall portion of theconnecting portion 166. The ridge portion 176 can include an uppersurface area, a distal sidewall portion, and proximal sidewall portionattached to the connecting portion 166. As shown, the proximal sidewallportion of the ridge portion 176 can be curved such that the width ofthe ridge portion 176 between the proximal and distal sidewall portionsvaries.

The ridge portions 174, 176 can help maintain the position of the anklestrap 154A on the dorsal shell 104. When the strap 154A is tightenedover the connecting portion 166 across the ankle of the user (best shownin FIG. 1), the strap 154A can compress the connecting portion 166 to adegree such that the lower surface area of the strap 154A descends belowthe upper surface areas of the ridge portions 174, 176. This can allowthe distal sidewall portion of the ridge 174 and the proximal sidewallportion of the ridge 176 to limit proximal and distal movement of thestrap 154A.

The ridge portions 174, 176 can help prevent the strap 154A from digginginto the ankle of the user. The connecting portion 166 can be arrangedsuch that compressive pressure or forces exerted on the connectingportion 166 by the strap 154A are substantially transferred from theconnecting portion 166 to the ridge portions 174, 176, and the uppersurfaces of the distal member 164 and the proximal portion 166 ratherthan the ankle and/or the foot.

While the connecting portion 166 is described forming a hinge mechanismbetween the proximal member 162 and the distal member 164, alternativehinge mechanisms can be used, such as pivot pins and sleeves, piano orbutterfly hinges, or other suitable hinge mechanisms can be used inplace of the connecting portion 166. For instance, one or more malleablebars or bars (not shown) can connect the proximal member 162 and thedistal member 164. The bars can be arranged as a metal stay such that aclinician or medical professional can selectively bend the bars tochange or set the aspect ratio of the proximal and distal members 162,164 relative to one another. This can help accommodate treatment ofAchilles tendon injuries, for example, where heel wedges are selectivelypositioned within the foot bed of the walker 100 by a medicalprofessional to adjust the angle of the user's foot within the foot bed.Optionally, the bars can be enclosed within a protective member such asan overmold portion to provide a comfort fit.

Referring now to the proximal member 162 best shown in FIG. 8A, aplurality of apertures 120 can be formed in the proximal member 162. Theapertures 120 can exhibit any suitable configuration. The apertures 120can have a periphery having opposed parallel longitudinal sidewallportion and curved or rounded end wall portions. The apertures 120 canbe arranged in two columns extending at least a portion of the distancebetween the proximal edge of the proximal member 162 and the distal edgeof the proximal member 162. The columns can be located on opposite sidesof the longitudinal axis of the dorsal shell 104.

Some or all of the apertures 120 can be slanted with a through-holeportion and a non-through hole portion. For example, one or more of theapertures 120 can include two through-holes separated by a non-throughhole. Similar to the apertures in the base shell 102, the apertures 120can help venting by allowing air to flow into and out of thethrough-hole portion. The apertures 120 can help reduce the weight ofthe walker 100 by reducing the amount of material in the dorsal shell104. The apertures 120 also may help strengthen the dorsal shell 104 byreinforcing the proximal member 162 with the material remaining in thenon-through hole portion of the aperture 120.

A flexible or resilient edge portion 178 can be formed on the proximalterminal end of the proximal member 162. The flexible edge portion 178can exhibit any suitable configuration and can be formed via anysuitable technique as discussed above. The flexible edge portion 178 caninclude a periphery, a generally convex upper surface area, a distalsidewall portion attached to the proximal member 162, a proximalsidewall portion, and a generally concave lower surface area. The distalsidewall portion of the flexible edge portion 178 can extend along agenerally wavy line defining a valley in the tibial crest area of theuser.

The flexible edge portion 178 can bend or flex when the leg of the userpushes on the flexible edge portion 178. The flexible edge portion 178can bend or flex when the proximal member 162 becomes angled or pitchedtoward the user's lower leg. This can allow the flexible edge portion178 to act as an expansion mechanism to accommodate different sizedlower legs of different users, providing a comfortable fit for differentusers having different sized anatomies. The bending or flexing of theflexible edge portion 178 can also reduce and/or eliminate thelikelihood of pressure points on the tibia, increasing the comfort ofthe walker 100 and providing tibia relief.

Optionally, a tibia relief portion 180 of the flexible edge portion 178can angle, curve, or radially extend away from the other portions of theupper surface area of the flexible edge portion 178 or the user's leg,spacing the tibia relief portion 180 of the flexible edge portion 178 adistance away from the user's leg. This can provide additional space forthe tibial crest, allowing the flexible edge portion 178 to betteraccommodate the tibial crest as the user walks. This can also helpreduce the likelihood of pressure points or edge pressures on the leg ortibia from the dorsal shell 104. For instance, because the tibia reliefportion 180 extends away from the lower leg, as the user's lower legpushes against the flexible edge portion 178, the user's leg can bend orflex the flexible edge portion 178 further away from proximal member162, reducing pressure points or edge pressures on the leg from thedorsal shell 108. The tibia relief portion 180 can be arranged to bendaway from the leg and toward an outer surface of the proximal member162. In other embodiments, the flexible edge portion 178 can be omitted.

A compliance strap guide 182 can be formed on the dorsal shell foraccommodating a compliance strap. A compliance strap is a strap that canbe used to deter a user or patient from prematurely or frequentlyremoving a walker, which can disrupt the healing process of the foot.

Another exemplary embodiment of a walker 300 is shown in FIG. 10. Thisembodiment includes a base shell 302, a dorsal shell 304, and acompliance strap guide 382 can be positioned on an anterior aspect of aproximal member 362 of the dorsal shell 304. A compliance strap assembly384 can comprise a compliance strap 386 arranged through the compliancestrap guide 382 and irreversibly attached to itself via an adhesive.When the compliance strap 386 is used with the walker 300, the dorsalshell 304 cannot be moved away from the base shell 302, preventingremoval of the walker 300 from the user's foot.

Locating the guide 382 on the anterior aspect can help increase theusability of the guide 382. For instance, when the walker 300 is placedon a user by a medical professional, the medical professional istypically situated in front of the walker 300. The position of thecompliance strap guide 382 on the anterior aspect of the proximal member362 allows the medical professional to more easily install a compliancestrap on the walker through the guide 382. This also allows thecompliance strap guide 382 to be positioned such that it will not rubagainst and/or damage an unaffected limb of the user during use of thewalker 300.

The compliance strap 386 can comprise a strap including high-densitypolyethylene fibers (e.g., a Tyvek® strap) arranged through thecompliance strap guide 382 and irreversibly attached to itself via anadhesive such that the compliance strap cannot be removed from thewalker 300 by sliding the compliance strap up and over the walker 300.The compliance strap 386 can only be removed by cutting or damaging thestrap 386, preventing removal of the walker without a clinician ormedical professional knowing. It will be appreciated that that thecompliance strap guide 382 and the compliance strap 386 are exemplaryonly, and other suitable configurations are possible. For instance, thebase shell 302 can include a recess or other feature suitable to receivea compliance strap.

Another exemplary embodiment of a compliance strap assembly 484 is shownin FIG. 11-13. The compliance strap assembly 484 can include acompliance strap 486 and a compliance clasp 488. The compliance strap486 can be formed of any suitable material such as, but not limited to,nylon and/or high-density polyethylene fibers.

The compliance clasp 488 can include a base member 490 and a door member492 pivotally attached to one another. A living hinge 494 can be formedbetween the base member 490 and the door member 492. The living hinge494 can be arranged to allow a clinician or medical professional toclose the compliance clasp 488 with one hand applying tension to thecompliance strap 486 and the other hand bringing the door member 492 andthe base member 490 together. Alternatively, the base member 490 can beformed as a separate piece from the door member 492 and pivotallyattached thereto in any suitable manner.

The base member 490 and the door member 492 can exhibit any suitableconfiguration. For instance, each of the base member 490 and the doormember 492 can exhibit a generally rounded rectangular shape having aperiphery, an upper surface area, and a lower surface area. In otherembodiments, the base member 490 and the door member 492 can exhibit agenerally triangular shape, a generally diamond shape, a generally ovalshape, combinations thereof, or any other suitable shape.

A pair of strap guides 496 can be formed on the upper surface of thebase member 490 for receiving an end portion of the compliance strap486. The strap guides 496 can be arranged to maintain alignment of thecompliance strap 486 with the compliance clasp 488, reducing thelikelihood that the compliance strap 486 will interfere with the doormember 492 in a closed position described below.

A receiving loop 498 can also be formed on the base member 490 forproviding an attachment point for one end of the compliance strap 486.This advantageously allows the one end to be attached to the receivingloop 498 and the other end of the compliance strap 486 to be loopedthrough a compliance strap guide (e.g., guide 382), around the walker(e.g., walker 300), through the strap guides 496, and attached toitself.

Referring to FIGS. 12 and 13, a plurality of recesses 401 can be formedin the upper surface of the base member 490. A plurality of spike-likeprotrusions 403 can be formed on the lower surface area of the doormember 492 that correspond to the plurality of recesses 401. Thespike-like protrusions 403 can include a wider base portion 403A,providing additional strength to the spike-like protrusions 403.

The compliance clasp 488 can be moveable between an open position (shownin FIG. 12) in which the door member 492 is rotated away from the basemember 490, and a closed position in which the lower surface area of thedoor member 492 is rotated onto the upper surface area of the basemember 490. When the compliance clasp 488 is in the closed position, thespike-like protrusions 403 penetrate the recesses 401 to lock or graspthe portion of the compliance strap 486 extending between the basemember 490 and the door member 492 within the compliance clasp 488.

The spike-like protrusions 403 and the recesses 401 can be arranged inany suitable manner. The spike-like protrusions 403 and the recesses 401can be generally upright. The spike-like protrusions 403 and therecesses 401 can extend at one or more angles. For instance, thespike-like protrusions 403 and the recesses 401 can extend at one ormore angles configured to allow for limited one-way movement of thecompliance strap 486 with the compliance clasp 488 in the closedposition. This can allow a clinician or medical professional to tightenthe compliance strap 486 with the compliance clasp 488 in the closed orposition.

The spike-like protrusions 403 can be arranged to at least partiallypierce the compliance strap 486. Applying tension to the compliancestrap 486 when the compliance clasp 488 is in the closed position cantear the strap 486 or break one or more of the spike-like protrusions403. Thus, if a non-compliant patient removes the compliance clasp 488from the strap 486 to remove the walker 300, the clinician or medicalprofessional will know upon examination of the compliance assembly 484.

One or more detents 405 may be formed on and extend from the lowersurface of the door member 492. One or more locking grooves 407corresponding to the detents 405 can be formed in the upper surface ofthe base member 490. The locking detents 405 can engage the lockinggrooves 407 when the compliance clasp 488 is in the closed position,creating an irreversible closure.

This allows the compliance clasp 488 to be irreversibly locked in thelocking position, preventing a user from removing the compliance clasp488 from the strap 486 without breaking or damaging the strap 486 and/orthe compliance clasp 488. As seen, the detents 405 and the lockinggrooves 407 can be concealed within the compliance clasp 488 when thecompliance clasp 488 is in the closed position, preventing the user fromover-riding or tampering with the locking mechanism of the complianceclasp 488.

The compliance clasp 488 can be formed from any suitable material. Thecompliance clasp 488 can include metals, such as aluminum, carbon,composite materials, such as carbon fiber/epoxy composites, glassfiber/epoxy composites, or suitable plastic materials, such asthermoplastic or thermosetting polymers, fiber reinforced plastic,molded chopped fibers, or any other suitable material. Differentportions of the compliance clasp 488 can be formed from differentmaterials. For instance, one portion of the compliance clasp 488 can beformed form polypropylene (e.g., the living hinge) and another portioncan be formed by a metal insert (e.g., the spike-like protrusions).

While the door member 492 is described including the spike-likeprotrusions 403 and the base member 490 is described including therecesses 401, it will be appreciated that the door member 492 mayinclude the recesses and the base member 490 may include the spike-likeprotrusions. Moreover, it will be appreciated that the door memberand/or the base member may include any suitable numbers of spike-likeprotrusions and/or recesses. Further, the compliance clasp 488 caninclude any suitable feature to lock or grasp the compliance strap 486between the base and door members.

Another exemplary embodiment of a compliance clasp 588 is illustrated inFIG. 14. The compliance clasp 588 can be similar to the compliance clasp488, except that base member 590 includes a first plurality of teeth 501formed in the upper surface of the base member 590 and the door member592 includes a second plurality of teeth 503 of complementary shape inthe lower surface of the door member 592 for interlocking with the firstplurality of teeth 501 of the base member 590.

When the compliance clasp 588 is in the receiving position, thecompliance strap can easily slide through the strap guides 596 on thebase member 590 to adjust the location and/or tension in the strap. Whenthe compliance clasp 588 is moved into the closed position, the teeth501 of the base member 590 engage the teeth 503 of the door member 592to lock or grasp the compliance strap within the compliance clasp 588.Similar to the compliance clasp 488, the compliance clasp 588 caninclude detents 505 and locking grooves 507 arranged to irreversiblylock the compliance clasp 588 in the closed position.

Another exemplary embodiment of a walker 600 is shown in FIGS. 15-28.The walker 600 can be similar to the walker 100 except that the walker600 includes an inflation system 601 arranged to reduce pressure pointswithin the walker 600, accommodate different sized anatomies, and/or toaccommodate swelling.

As can be seen from FIGS. 15 and 16, the walker 600 includescomplementary base shell 602 and dorsal shell 604 and a plurality ofstraps 654 arranged to bring the base shell 602 and the dorsal shell 604closer together. The plurality of straps 654 can include an ankle strap654A, an upper strap 654B, and a foot strap 654C. A soft good liner 612can be provided inside the base shell 602 and the inflation system 601can be integrated on the interior and/or the exterior of the walker 600.

For simplicity, FIG. 17 shows the inflation system 601 removed from thewalker 600 according to an embodiment. The inflation system 601 caninclude a pump assembly 603, one or more inflation tubes 605, and aninflatable bladder 607. The inflatable bladder 607 can be arranged in anankle receiving portion of the walker 600 (best shown in FIG. 27) andinflated and/or deflated via the one or more inflation tubes 605, whichare in fluid communication with the pump assembly 603. Optionally, theinflation system 601 can include a pressure relief valve assembly 609that can automatically expel excess air from the inflation system 601,reducing the likelihood of over-inflation that can harm the user.

As best shown in FIGS. 15 and 20, the pump assembly 603 can be connectedto the inflation tube 605 and can be attached to and/or carried by theupper strap 654B. Arranging the pump assembly 603 on the upper strap654B can allow the pump assembly 603 to be in a relatively fixedposition with respect to the base shell 602. As the location of thedorsal shell 604 moves up and down as a user moves or to accommodatevariations in user anatomy, the position of the pump assembly 603relative to the base shell 602 can remain substantially fixed on theupper strap 654B. This has the effect of preventing kinking of theinflation tubes 605 and/or unwanted movement of the pump assembly 603that could inadvertently inflate or deflate the inflatable bladder 607.Arranging the pump assembly 603 on the upper strap 654B on the anteriorof the walker 600 can also make the pump assembly 603 more usable andaccessible to a user.

Optionally, the pump assembly 603 can be permanently attached to thestrap 654B so that the pump assembly 603 is not easily misplaced. Theupper strap 654B may be generally flexible, allowing the pump assembly603 to generally conform to the shape of the dorsal shell 604 below thestrap 654B, regardless of the anterior and/or posterior position of thedorsal shell 604 relative to the strap 654B.

It will be appreciated that the location of the pump assembly 603 on theanterior region of the upper strap 654B is exemplary only, as othersuitable locations of the pump assembly 603 are possible. For example,the pump assembly 603 can be located on the ankle strap 654A. The pumpassembly 603 can be arranged on the lateral region of the upper strap654B or the exterior of the base shell 602 in the lower leg region ofthe walker 600.

As seen in FIG. 18, the pump assembly 603 can include a cover 611, apump 613, a fill valve 615, and a release valve 617. The cover 611 canbe arranged to house the pump 613, the fill valve 615, and the releasevalve 617. The cover 611 can exhibit any suitable configuration. Thecover 611 can be made from any suitable flexible, resilient, orcompliant material. The cover 611 can include one or more vent openingsto allow air vented from the inflatable bladder 607 to pass through thecover 611 to the atmosphere.

Optionally, the cover 611 can include one or more enhancement features619, such as raised or recessed portions, which can be configured in anysuitable design. For example, the enhancement features 619 may beconfigured as a cross “+” indicating inflation and an elongated recess“−” indicating deflation. The enhancement features 619 can also helpenhance function and/or gripping so that a user can more easily actuatethe pump 613 and/or the release valve 617. The enhancement features 619can also provide visual and/or tactile indicators for the user. Thecover 611 can further include one or more features to wrap around thestrap 654B for better securement of the pump assembly 603 to the strap654B. As noted above, the cover 611 can exhibit any suitableconfiguration.

The pump 613 is housed within the pump cover 611 and can comprise anysuitable pump type. For example, the pump 613 can be a diaphragm orpositive displacement pump including a diaphragm or body 621, an inlet623, and an outlet 625. The inlet 623 can be formed in one end of thebody 621 and can allow air to flow into the body 621. The inlet 623 canalso be selectively closed when the pump 613 is actuated so that airdoes not flow out of the pump 613 through the inlet 623. Optionally, theinlet 623 can be arranged as a release valve or the pressure reliefvalve described below. The outlet 625 can be opposed to the inlet 623 onthe other side of the body 621. A one-way valve assembly 627 can beprovided within the outlet 625 for allowing air to pass from the pump613 into the inflatable bladder 607, but not from the inflatable bladder607 to the pump 613.

In operation, when the diaphragm or body 621 of the pump 613 moves up(e.g., volume increases), pressure within the pump 613 decreases,causing air to be drawn into the pump through the inlet 623. When thebody 621 of the pump 613 moves down (e.g., volume decreases), thepressure in the pump 613 increases, forcing the air that was previouslydrawn in out of the pump 613 through the outlet 625. Finally, the body621 moving up once again draws air into the pump 613.

The pump 613 can have any suitable shape and size. For instance, thepump can include a generally box-like shape with a convex anterior sideand/or a convex posterior side. The shape of the pump can be arranged tomaximize the useable stroke volume of the pump 613.

The release valve 617 can be arranged to selectively release pressurewithin the inflatable bladder 607 and/or the inflation system 601. Therelease valve 617 can be incorporated with the pump 613. The releasevalve 617 can be incorporated with the pump assembly 603. The one-wayoutlet valve assembly 627 can communicate with the inflatable bladder607 via the release valve 617. The release valve 617 can be activatedmanually by a user. The release valve 617 can be separate from the pumpassembly 603. The release valve 617 can be located at any suitablelocation on the walker 600.

Alternatively, the pump 613 and/or release valve 617 can be electricallypowered by a portable power source associated with the walker 600. Thepump 613 can be configured to be usable with fluid or liquid. Forexample, the pump 613 can be usable with liquid to provide hot and/orcold therapy.

FIG. 19 illustrates a pump assembly 703 according to another embodiment.The pump assembly 703 can include a pump 713 having an elongatedovoid-like shape including a maximum dimension between the anterior andposterior sides at a center of the pump 713 that tapers toward each endof the pump 713. A larger, more elongate cover 711 can cover the pump713 and a release valve 717. The shape of the pump 713 can be arrangedto maximize the useable stroke volume of the pump 713.

As seen in FIG. 20, a tube hole 662 can be formed in the proximal wingportion 610 of the base shell 602 for receiving the inflation tube 605exiting the pump assembly 603. The tube hole 662 can exhibit anysuitable configuration. The tube hole 662 can comprise a semi-ellipticalrelieved portion or cutout on a strap slot 656 in the proximal portionof the wing portion 610. The tube hole 662 can be separate from thestrap slot 656. The tube hole 662 can be elongated, circular, or canexhibit any other suitable shape. While one tube hole 662 is shown inthe wing portion 610, in other embodiments, two, three, four, or anyother number of tube holes 662 are possible.

The inflation tube 605 exiting the pump assembly 603 can be threadedfrom the interior of the base shell 602 through the tube hole 662. Fromthe tube hole 662, the inflation tube 605 is guided or routed along theexterior of the base shell 602 to the posterior aspect of the base shell602 where it is connected to the pressure relief valve assembly 609(shown in FIG. 21), positioned under a cover member 664 attached to theposterior aspect of the base shell 602.

The inflation tube 605 can be flexible so that the inflation tube 605can generally conform to the contour of the base shell 602. Theinflation tube 605 can include one or more segments sized and shaped togenerally contour the exterior of the base shell 602. For example, atleast one of the segments of the inflation tube 605 can include one ormore bends that generally contours the bends or curves in the exteriorof the base shell 602. In other embodiments, the inflation tube 605 canbe routed in grooves formed on the interior surfaces of the base shell602.

A fabric sleeve 628 can be located on the upper strap 654B for guidingthe inflation tube 605 along the outside of the base shell 602 from thepump assembly 603 to the pressure relief valve assembly 609 within thecover member 664. The fabric sleeve 628 can comprise a unitary sleeve ora plurality of discrete portions of the sleeve 628. The fabric sleeve628 can comprise an integrated portion of the upper strap 654B. Forinstance, the fabric sleeve 628 can comprise vertical cutouts in theupper strap 654B into which the inflation tube 605 can be interwoven.

Routing the inflation tube 605 on the outside of the base shell 602 canhelp reduce or eliminate pressure points on the interior or inside ofthe walker 600, which can be both uncomfortable as well as a risk forresulting in pressure ulcers. Further, routing the inflation tube 605 onthe outside of the base shell 602 protects the inflation tube 605 frombeing pinched or compressed between the interior of the walker 600 andthe leg of the user.

It will be appreciated that the inflation tube 605 can exit the pumpassembly 603 in any suitable manner. For example, the inflation tube 605can be routed in one or more indentations or grooves formed in theexterior or interior surface of the base shell 602. The inflation tube605 can be routed through guides (e.g., rings or clips) attached to theexterior of the base shell 602, between the upper strap 654B and theexterior of the base shell 602, or in any other suitable arrangement.

For simplicity, FIG. 21 is a partial view of the posterior of the baseshell 602 with the cover member 664 removed. As shown, the inflationtube 605 connects to the pressure relief valve assembly 609, which ishoused within a cavity or cutout 631 formed in the base shell 602. Thecutout 631 can have any suitable configuration. The cutout 631 canextend completely between the interior and exterior surface of the baseshell 602. The cutout 631 can have a generally rectangular shape, agenerally trapezoidal shape, a shape that generally corresponds to theshape of the pressure relief valve assembly, or any other suitableshape.

A pair of strap slots 656 can be formed on opposing sides of the cutout631. The upper strap 654B can pass from the exterior of the base shell602 and through a strap slot 656, situating the upper strap 654B behindthe pressure relief valve assembly 609. The strap 654B can then extendthrough the other strap slot 656 back to the exterior of the base shell602. This allows the strap 654B to form a protective barrier between thepressure relief valve assembly 609 and the user's leg.

The cover member 664 can be attached the base shell 602 over the cutout631 and the pressure relief valve assembly 609. The cover member 664 caninclude a base portion 633 and a peripheral sidewall 635 arranged toextend from the base portion 633 toward the base shell 602 of the walker600.

A recess 639 in the cover member 664 is bounded the sidewall 635 and thebase portion 633 so that the bottom of the recess 639 is above (recessedwithin) the rim 637 of the sidewall 635 to provide a space for thepressure relief valve assembly 648. This can allow the base portion 633and the sidewall 535 to substantially enclose the pressure relief valveassembly 609 within the recess 639, protecting the pressure relief valveassembly 609 within the cutout 631 and helping to deter tampering.

The sidewall 635 defines a rim 637 extending around the base portion633. At least a portion of the rim 637 can be contoured to generallycorrespond to the contour of the posterior of the base shell 602. Thiscan allow the cover member 664 to form a better fit between the covermember 664 and the base shell 602. The rim 637 can also provide asupport area for the cover member 664 when the cover member 664 isattached to the base shell 602. Optionally, one or more ribs 643 can beformed on the rim 637 arranged to crush during attachment of the covermember 664 to the base shell 602 to accommodate variations in thegeometry of the base shell 602.

One or more side openings 641 can be formed along the rim 637 of thesidewall 635 for accommodating a portion of the inflation tubes 605. Oneside opening 641 can be arranged to accommodate a portion of theinflation tube 605 extending between the pump assembly 603 and thepressure relief valve assembly 609. Another side opening 641 can bearranged to accommodate a portion of the inflation tube 605 extendingbetween the pressure relief valve assembly 609 and the inflatablebladder 607.

The cover member 664 can be attached to the base shell 602 in anysuitable manner. The cover member 664 can be secured to the base shell602 via a snap-type connection. The cover member 664 can include aplurality of snaps or hook members 629 integrally formed in the sidewall635 and configured to snap into the cutout 631 formed in the base shell602, facilitating assembly. The cover member 664 can be attached to thebase shell 602 via gluing or plastic welding. Alternatively, the covermember 664 can be removably attached to the base shell 602 viafasteners, hook-and-loop type systems, clips, magnets, or any othersuitable attachment system.

By arranging the pressure relief valve assembly 609 within the cutout631 and cover member 664, the pressure relief valve assembly 609 can beprotected from damage due to accidental contact with external objects.Moreover, the cover member 664 can help limit or eliminate pressurepoints from components of the inflation system 601 (e.g., the pressurerelief valve assembly). The cover member 664 can be used with othercomponents of the inflation system 601. The cover member 664 can also beinterchangeable based on needs for various indications such as anadjustable relief valve or housing an activity monitor.

The location of the pressure relief valve assembly 609 on the posteriorof the base shell 602, helping to deter tampering. In other embodiments,the pressure relief valve assembly 609 can be incorporated in theinflatable bladder 607, on the lateral side of the base shell 602, or inany other suitable position.

The pressure relief valve assembly 609 can exhibit any suitableconfiguration. Referring now to FIGS. 22 and 23, the pressure reliefvalve assembly 609 can comprise a pressure relief valve 643 including avalve body 645 having a first port 647, a second port 649, and a thirdport 651. A first fluid pathway 653 connects the second port 649 and thethird port 651. A second fluid pathway 655 connects the first fluidpathway 653 and the first port 647. The first port 647 of the valve body645 is connected to the inflation tube 605 extending between the pumpassembly 603 and the pressure relief valve 643. The second port 649 isconnected to the inflation tube 605 extending between the pressurerelief valve 643 and the inflatable bladder 607. As seen, the first port647 can be at about a 90 degree angle relative to the second port 649.

The first port 647 and the second port 649 can be connected to theinflation tubes 605 in any suitable manner. For example, in theillustrated embodiment, the first port 647 and the second port 649 canbe connected to the inflation tubes 605 via a barb-type connection. Theinflation tubes 605 can be attached to the pressure relief valve 643 viasolvent bonding, friction or spin welding, adhesives such as a UV cureadhesive, or any other suitable attachment means.

The valve body 645 further includes an upper portion 657 that can haveany suitable configuration. The upper portion 657 comprises a generallycylindrical member including a bottom opening that is in fluidcommunication with the third port 651 and one or more vent openings 659in the side thereof for venting air to the atmosphere. The bottom of theupper portion 657 can include a surface surrounding a bottom openingthat forms a valve seat 661 for a sealing member 663.

The upper portion 657 is generally hollow, providing a space for thesealing member 663. The sealing member 663 can comprise an elastomericdisk having a diaphragm shape or an umbrella shape positioned within theupper portion 657. The sealing member 663 can comprise a disk having agenerally Belleville spring washer shape that includes stem portion 665.An upstream side of the sealing member 663 can be situated within thefirst fluid pathway 653 and a downstream side can be situated betweenthe sealing member 663 and a retainer member 667. The sealing member 663can be formed from any suitable material such as silicone and/or otherelastomeric materials.

The retainer member 667 is arranged to retain the sealing member 663within the upper portion 657 of the valve body 645. The retainer member667 can comprise a generally cylindrical member including a stem havinga recessed or hollow portion configured to receive and hold the stemportion 665 of the sealing member 663 in place.

The retainer member 667 may be a separate component from the valve body645. The upper portion 657 can include a plurality of detents or catches671 and the retainer member 667 can include a plurality of correspondinglocking apertures 673 extending between the top and bottom surface ofthe retainer member 667. The locking apertures 673 can engage thedetents 671 of the upper portion 657 when the retainer member 667 ispositioned on the upper portion 657 so that the retainer member 667snaps over the upper portion 657 of the valve body 645 and is lockedthereon.

Raised portions 675 can be situated between the detents 671, providing asupport surface for the retainer member 667 when the retainer member 667is snapped over the upper portion 657. This arrangement can help ensurethat the distance from the valve sealing surface to the retainer member667 is controlled, which acts to control compression of the sealingmember 663 and thereby the valve cracking pressure. Alternatively, theretainer member 667 may be integral to the valve body 645. For example,the retainer member 667 could be integrated into the valve body 645 viaa hinged snap.

The pressure relief valve 643 is movable between the closed position,wherein the third port 651 is sealed by sealing member 663, and the openposition, wherein the third port 651 is unsealed, such that air or otherfluids may flow, from the inflatable bladder 607 and/or pump 613 throughthe first and second fluid pathway 653, 655 to atmosphere.

When the sealing member 663 is mounted in the valve seat 661, thesealing member 663 can have a generally convex shape that flattens outagainst the valve seat 661 to create a certain sealing force thatmaintains the pressure relief valve 643 in the closed position. Thesealing member 663 can use at least in part its elastic materialproperties and its preloaded convex shape to create the sealing forceagainst the valve seat 661.

When the internal pressure within the inflation system 601 or headpressure creates enough force to lift or pop the sealing member 663 fromthe valve seat 661 of the upper portion 657, the third port 651 isunsealed and air can be vented from the inflatable bladder 607 and/orinflation system 601 to atmosphere. The stem 665 of the sealing member663 positioned within the retainer member 667 can form a hinge aboutwhich disc portion of the sealing member 663 pops between its convexshape and a more flattened or concave shape in which the disc portion ofthe sealing member 663 lifts away from the valve seat 661 of the upperportion 657.

The pressure at which the sealing member 663 lifts off of the valve seat661 is called the cracking pressure. When the head pressure is less thanthe cracking pressure, the sealing member 663 can automatically pop backclosed. The cracking pressure of the pressure relief valve 643 can begreater than about 40 mmHg, about 50 mmHg, about 55 mmHg, about 60 mmHg,or about 65 mmHg. In other embodiments, the cracking pressure of thepressure relief valve 643 can be between about 40 mmHg and about 70mmHg, about 45 mmHg and about 65 mmHg, or about 50 mmHg and about 60mmHg. In other embodiments, the cracking pressure may be greater orlower. The cracking pressure of the pressure relief valve 643 can be setor varied by varying the shape and/or elastomeric properties of thesealing member 663.

The cracking pressure of the pressure relief valve 643 can be selected,set, or adjusted to generally correspond to a selected pressure limitwithin the inflatable bladder 607. The selected pressure limit cancomprise a safe operating pressure, a therapeutic pressure, an activityspecific pressure, a treatment pressure, or any other suitable pressurelimit.

Alternatively, the retainer member 667 can be threadedly attached to theupper portion 657 of the valve body 645 such that the height of theretainer member 667 relative to the sealing member 663 can be adjusted,which, in turn, can influence the cracking pressure of the sealingmember 663 by adjusting the force exerted on the sealing member 663 bythe retainer member 667. Thus, the cracking pressure can be adjusted byadjusting the position of the retainer member 667 relative to thesealing member 663. The cracking pressure adjustment can be made by theuser based on their activity level. For instance, a higher pressuresetting could be used for periods of high activity like walking, while alower pressure setting could be used for periods of rest.

In use, when the inflatable bladder 607 is inflated to point where theinternal pressure within the inflation system 601 or head pressure onthe sealing member exceeds the cracking pressure of the pressure reliefvalve 643, the pressure relief valve 643 can automatically move to theopen position, thereby expelling or releasing air from the inflationsystem 601 and/or inflatable bladder 607 to atmosphere through the thirdport 651 of the pressure relief valve 643. As air is released from theinflation system 601, the internal pressure within the inflation system601 can drop below the cracking pressure of the pressure relief valve643 such that the pressure relief valve 643 automatically returns to theclosed position, thereby resealing the inflation system 601.

Because the pressure relief valve 643 automatically limits or regulatesthe level of pressure within the inflation system 601, the pressurerelief valve 643 can reduce the likelihood that a user will over-inflatethe inflatable bladder 607. This is advantageous because users ofwalkers and other orthopedic devices, especially diabetic patients,often experience reduced sensation in their extremities, which canresult in them inadvertently over-inflating the inflatable bladder 607.Such over-inflation can cause pressure on the skin, which can reduceboth capillary blood flow to the skin and arterial flow to theanatomical member. Thus, by limiting or automatically regulating thelevel of pressure within the inflatable bladder 607 and/or inflationsystem 601, the pressure relief valve 643 eliminates or reduces thelikelihood of over-inflation that can harm the user.

In addition, the pressure relief valve 643 can automatically releaseexcess pressure within the inflation system 601 resulting from otherfactors, such as, for example, changes in ambient pressure due to achange in altitude. The pressure relief valve 643 also reduces the needfor users themselves to set or monitor safe pressure levels within theinflation system 601. For example, conventional inflation systems oftenrequire patients to monitor pressure in the system using a pressuregauge attached to a pump. However, many patients, especially diabeticpatients, do not see well enough to read the pressure gauge and pressuregauges are known to malfunction. Consequently, such patients tend toover-inflate the inflatable bladder causing injury to the patient. Byincluding the pressure relief valve 643 in the inflation system 601, thepatient/user can inflate the inflatable bladder 607 without the need ofreading a pressure gauge or the risk of over-inflation.

The configuration of the pressure relief valve assembly 609 describedherein is to be regarded as exemplary only, as any suitableconfiguration of the pressure relief valve assembly is possible. Forexample, the pressure relief valve 643 can be a spring-loadedover-pressure relief valve, a check valve, a swing-check valve, adiaphragm valve, a ball valve, luer check valves, miniature checkvalves, or any other suitable valve. In other embodiments, the pressurerelief valve 643 can include, but is not limited to the Series 500Miniature Check Valves, commercially available from Smart Products,Inc., Morgan Hill, Calif., which are incorporated herein, in theirentirety, by this reference. Of course, other pressure relief valves maybe employed.

Another exemplary embodiment of a pressure relief valve assembly 709 isillustrated in FIGS. 24 and 25. The pressure relief valve assembly 709can comprise a pressure relief valve 743 similar to the pressure reliefvalve 643, except that retainer member 767, upper portion 757, andsecond port 749 exhibit a different configuration. As seen, the upperportion 757 can comprise a hollow substantially cylindrical memberhaving a generally solid sidewall. The upper portion 757 can includevent openings 759 formed in the sidewall for venting air the atmosphere.The inner surface of the upper portion 757 can include a plurality ofcatches 771 formed thereon, each including a generally planar bottomsurface area and an angled upper surface area. The retainer member 767can comprise a disc-like member sized and configured to snap inside ofthe upper portion 757. When the retainer member 767 is inserted orsnapped into the upper portion 757 of the valve body 745, the planarbottom surface areas of the catches 771 can form a stop by engaging thetop surface of the retainer member 767 to lock the retainer member 767within the upper portion 757.

The valve body 745 includes a first port 747, a second port 749, and athird port 751. A first fluid pathway 753 connects the first port 747and the second port 749. A second fluid pathway 755 connects the firstfluid pathway 753 and the third port 751.

Another exemplary embodiment of a pressure relief valve assembly 809 andcover member 864 is illustrated in FIG. 26. The pressure relief valveassembly 809 includes a pressure relief valve 843, a fitting 877, arelief tube 879 connected to the pressure relief valve 843, and theinflation tube 605. The fitting 877 may have any suitable configuration.For example, the fitting 877 may be a tee-type fitting having a firstport, a second port, and a third port. The fitting 877 can include afirst fluid pathway may extend between the second port and the thirdport and a second fluid pathway extending between the first port and thefirst fluid pathway. In an embodiment, the first port of the fitting 877is connected to the inflation tube 605 extending between to the pumpassembly 603 and the fitting 877. The second port of the fitting 877 isconnected to the inflation tube 605 extending through a tube hole 662(shown in FIG. 27) and between the fitting 877 and the inflatablebladder 607. As shown, the inflation tube 605 can be routed such that itat least partially loops around the pressure relief valve assembly 609.The third port can be connected to the relief tube 879 extending betweenthe fitting 877 and the pressure relief valve 843.

The pressure relief valve 843 can exhibit any suitable configuration.For example, the pressure relief valve 843 can include a valve bodyhaving a valve seat, a first port 847, a second port 849, and a fluidpathway extending between the first port 847 and the second port 849.

The pressure relief valve 843 can include a sealing member configured tocooperate with the valve seat in order to seal the second port 849. Thepressure relief valve 843 is movable between a closed position, whereinthe second port 849 is sealed by the sealing member, and an openposition, wherein the second port 849 is unsealed, such that air mayflow, for example, from the inflatable bladder 607 and/or pump assembly603 to the atmosphere. The pressure at which the pressure relief valve843 moves to the open position is the cracking pressure. In anembodiment, the sealing member can be biased against the valve seat toseal the second port 849 with the aid of a resilient retainer member. Inother embodiments, the sealing member can be held within the valve bodyby a retainer member and the sealing member can be configured to sealthe second port 849 based on the material properties and/or shape of thesealing member.

The pressure relief valve 843 can include means to adjust the resilientforce applied to the sealing member, such as a dial on the posterior ofthe base shell 602. The dial may be positioned on the base shell 602,integrated with the cover member 664, or in any other suitable location.By adjusting the resilient force, the cracking pressure of the pressurerelief valve 843 adjusts. Thus, the dial may have different settingssuch as high pressure, medium pressure, and low pressure. A user,clinician, or medical professional can select, set, or adjust thecracking pressure to customize the inflation system 601 for differentusers and/or user needs.

The cover member 864 can be similar to the cover member 664 except thatthe cover member 864 is larger and includes a u-shaped inner wall 881formed on the bottom of the recess 839. The u-shaped inner wall 881 canbe arranged to provide additional support and/or protection to thepressure relief valve assembly 809. The u-shaped inner wall 881 mayinclude side openings 841 formed along the rim thereof arranged toaccommodate and/or receive the inflation tubes 605. The inner wall 881can also help align the cover member 864 with the base shell 602. Forinstance, the inner wall 881 can fit into a corresponding groove orrecess formed on the base shell 602. This arrangement can eliminate theneed of hook members or snaps to withstand transverse loading.

A plurality of hook members 829 can be formed on and extending from thebottom of the recess 839. The hook members 829 can be arranged toselectively snap into the cutout 631. As shown, at least one of the hookmembers 829 can provide a support or guide for the inflation tube 605extending between the fitting 877 and the inflatable bladder 607. Itwill be appreciated that the cover member 864 can exhibit any suitableconfiguration.

FIG. 27 illustrates the base shell 602 with the liner removed forsimplicity. As seen, the posterior of the base shell 602 can includeanother tube hole 662 formed in a bottom wall of the cutout 631 that isin communication with the interior of the walker 600. The tube hole 662can exhibit any suitable configuration.

The inflation tube 605 connecting the pressure relief valve assembly 609and the inflatable bladder 607 can be inserted through the tube hole 662to the interior of the base shell 602 where an indentation or groove 883can be formed for guiding the inflation tube 605 to the inflatablebladder 607. The groove 883 can have any suitable configuration. Forexample, the groove 883 can extend from the tube hole 662 to a pointbelow the terminal edge of the inflatable bladder 607.

Routing the inflation tube 605 through the groove 883 on the interior ofthe base shell 602 can help reduce or eliminate pressure points on theinterior of the walker 600, which can be both uncomfortable as well as arisk for resulting in pressure ulcers. Guiding the inflation tube 605 inthe groove 883 can also protect the inflation tube 605 from beinginadvertently crushed or pinched. In other embodiments, the inflationtube 605 can be covered or secured into the groove 883 using adhesivetape, a separate cover component, or any other suitable means. As seen,the inflatable bladder 607 can be arranged within the posterior of thebase shell 602 such that when the inflatable bladder 607 is inflated,the inflatable bladder 607 can support the lower leg, ankle, and/orfoot.

The inflatable bladder 607 can be arranged in the ankle receivingportion of the base shell 602 and generally shaped to correspond to theposterior, medial, and lateral side of the base shell 602. As notedabove, observation holes 652 can be formed in the wing portions 610 ofthe base shell 602, allowing for tactile and/or visual confirmation thatthe inflatable bladder 607 is properly inflating or inflated.

The inflatable bladder 607 can include a posterior portion 685 and wingportions 687. The inflatable bladder 607 can be formed of two sheets ofair impervious plastic material that is welded around the edges tocreate air chambers therebetween. Optionally, perspiration wickingmaterial can be applied to the surfaces of the inflatable bladder 607that are configured to contact the wearer's anatomy.

The inflatable bladder 607 can be attached to the base shell 602 and/orliner 612 by a hook-and-loop type system, a snap-fit system,combinations thereof, or any other suitable attachment system. Forexample, a portion of the inflatable bladder 607 can be covered with aloop material (e.g., UBL loop) to make it easily attachable to acorresponding hook material on the base shell 602. In other embodiments,the inflatable bladder 607 can snap into or onto the base shell 602.Welds and/or holes 689 can be arranged in the inflatable bladder 607 toserve a number of functions. For example, the welds 689 in theinflatable bladder 607 can be configured to direct airflow within theinflatable bladder and also to provide heat and perspiration wickingchannels along the surfaces of the inflatable bladder 607.

The inflatable bladder 607 can include a central opening 691 having anhour-glass like shape. The central opening 691 can be configured toreceive and support the Achilles tendon so that the lower leg fitssnugly within the walker 600, and the ankle is securely positionedwithin the walker 600. In other embodiments, the inflatable bladder 607may include longitudinally extending openings (not shown) that provideventing for heat and perspiration. Moreover, the posterior of theinflatable bladder 607 can include a bridge portion that includes aninlet for the inflation tube 605 and this is in fluid communication withthe lateral and medial sides of the inflatable bladder 607. Such aconfiguration can help the inflatable bladder 607 inflate more equally,reducing the likelihood that one side inflates faster than the otherside.

The shape of the inflatable bladder 607 can further be configured tofocus compression where it is needed and uniform compression is providedto areas of the anatomy where the inflatable bladder 607 providescompression. In other embodiments, the shape of the inflatable bladder607 can be configured to create specific areas of pressure off-loading.The inflatable bladder 607 can be encased within a fabric covering,providing increased comfort to a user.

It will be appreciated that while a single inflatable bladder isdescribed, the walker 600 can include any suitable number of inflatablebladders. For example, in an embodiment, the walker 600 can includeseparate medial, lateral, and dorsal bladders. Moreover, while theinflatable bladder is described being inflated with air, it will beappreciated that the inflatable bladder can be filled with any suitablematerial or fluid. For example, the inflatable bladder 607 can beselectively filled with gel, foam, water, silicone, combinations thereofof the like. Moreover, in other embodiments, the inflatable bladder 607can be included as part of a liner within the walker 600. In otherembodiments, the inflatable bladder 607 is separate from a liner withinthe walker 600. Such a configuration may facilitate removal the linerfor washing or replacement.

While the inflation system 601 is shown with the walker 600, it will beappreciated that the exemplary embodiments of the inflation system canbe incorporated and/or used with a number of different orthopedicdevices. For instance, exemplary embodiments of the inflation system canbe used with a short leg walker, an ankle walker, a strut walker, afracture walker, an Achilles walker, or any other suitable orthopedicdevice. In other embodiments, the inflation system 601 can be integratedwith a system providing Deep Vein Thrombosis (“DVT”) therapy.

In other embodiments, the inflation system 601 can be arranged tocontrol the amount of pressure within the inflation system 601 based onsensed conditions. As seen in FIG. 28, an inflation system 601Aaccording to another embodiment can include a pressure regulation system693 having a control unit 695 and one or more sensors 697 arranged tosense pressure within the inflatable bladder 607 and/or inflation system601 and to send one or more sensing signals 699 to the control unit 695.The sensing signals 699 can include information about pressure levelswithin the inflatable bladder 607 and/or inflation system 601. Thecontrol unit 695 can be operably connected to the pump 613 and therelease valve 617 and/or the pressure relief valve assembly 609 suchthat the control unit 695 can direct the pump the 613 to inflate theinflatable bladder 607 and the release valve 617 and/or the pressurerelief valve assembly 609 to deflate the inflatable bladder 607 inresponse to the pressure information received from the one or morepressure sensors 697.

For instance, the one or more sensors 697 can detect strain (ordeflection) due to pressure over an area in the inflatable bladder 607and/or the inflation system 601. The one or more sensors 697 can convertthis pressure energy to the one or more sensing signals 699 in the formof electrical energy. One or more analog-to-digital converters (ADC)convert the electrical energy to digital data that is provided to thecontrol unit 695. The ADC can be a separate component, can be integratedinto the control unit 695, or can be integrated into the one or moresensors 697. The control unit 695 can include processing hardware (e.g.,processing electrical circuitry) and an operating system configured torun one or more application software programs. The control unit 695 canuse one or more processing techniques to analyze the digital data inorder to determine pressure levels within the inflatable bladder 607and/or inflation system 601. Responsive to the one or more sensingsignals 699 output by the one or more sensors 697, the control unit 695(including control electrical circuitry) can direct the pump 613 toinflate the inflatable bladder 607 or the release valve 617 to deflatethe inflatable bladder 607, automatically controlling safe pressurelevels within the inflation system 601. In other embodiments, thecontrol unit 695 can direct the pressure relief valve assembly 609 todeflate the inflatable bladder 607 responsive to the one or more sensingsignals 699.

Another exemplary embodiment of an orthopedic device comprising a walker900 is shown in FIGS. 29-31. Similar to the other embodiments, thewalker 900 includes complementary base and dorsal shells 902, 904 and atleast one strap 906 arranged to bring the base shell 902 and the dorsalshell 904 closer together. The at least one strap 906 can comprise anupper strap arranged to extend over a patient's lower leg. A pumpassembly 908 is attached to and/or carried by the at least one strap 906along the anterior aspect of the walker 900 and an inflatable bladdercan be arranged in an ankle receiving portion of the walker 900 andinflated and/or deflated via one or more inflation tubes 910, which arein fluid communication with the pump assembly 908. The pump assembly 908can include a pump to increase pressure within the inflatable bladderand a release valve arranged to selectively release pressure within theinflatable bladder.

As can be seen from the figures, this embodiment includes a protectivepart 914 securable over the pump assembly 908 of the walker 900. Theprotective part 914 is arranged to protect the pump assembly 908 fromdamage and/or inadvertent operation due to contact with externalobjects. For instance, walkers are commonly used in combination with aknee scooter 901 (or knee walker or a platform walker) as shown in FIG.30. A knee scooter 901 allows a patient to propel oneself with one leg,while the patient's affected leg rests on a support platform 903 of theknee scooter 901.

As seen in FIG. 30, when riding a knee scooter 901, the patienttypically positions the anterior aspect of the walker 900 on the supportplatform 903 to support the weight of the patient on the knee scooter901. With the pump assembly 908 positioned on the anterior aspect of thewalker 900, the weight of the patient on the walker can force orcompress the pump assembly 908 against the support platform 903 of theknee scooter, which, in turn, can damage or inadvertently operate thepump assembly. This can be problematic because it can damage the pumpassembly and/or over inflate the inflatable bladder inside the walker,which can cause pressure on the skin and reduce both capillary bloodflow to the skin and arterial flow to the affected limb. This can alsobe problematic because it can under inflate the inflatable bladder inthe walker, which can result in a poor fit and/or inadequate support forthe affected limb. Also problematic is that leaning on the anterioraspect of the walker 900 can deflate the inflatable bladder bydepressing the release valve.

The protective part 914 advantageously protects the pump assembly 908from damage and/or inadvertent operation by providing a physical barrierbetween the pump assembly 908 and an external object (e.g., the supportplatform 903). For instance, when the anterior aspect of the walker 900is positioned on the support platform 903, the rigidity of theprotective part 914 distributes the user's weight on the walker 900 awayfrom the pump assembly 908 and directly to the support platform 903,eliminating or substantially reducing any load on the pump assembly 908from the patient's weight. This advantageously protects the pumpassembly 908 from being inadvertently compressed between the walker 900and the support platform 903, reducing the likelihood of the pumpassembly 908 being damaged or undesirably operated, which in turn,increases patient safety, convenience, and freedom to use the walker 900with a knee scooter.

The protective part 914 protects the pump assembly 908 withoutsubstantially affecting the functionality of the walker 900. It alsodoes so without the use of complicated and bulky components.Furthermore, the protective part 914 can be a separate add-on componentto the walker and can be adapted to fit a number of different orthopedicdevices, providing versatility.

As shown in FIG. 31, the protective part 914 can include a semi-rigid orrigid body 912 defining an inner surface 918 arranged to engage and/orface the dorsal shell 904, an outer surface 920 opposite the innersurface 918, and side surfaces 922 extending between the inner and outersurfaces 918, 920. The body 912 is formed of at least one materialhaving a rigidity or strength selected to resist impact loads and/orsustained loads when it is secured on the walker 900. The body 912 canbe formed of plastic, foam, carbon fiber, metal, combinations thereof,or any other material which would provide sufficient strength to resistundesirable deformation during use. In an embodiment, the body 912 canbe formed of a high density foam so that it can provide some cushioningand/or shock absorption. For instance, the body 912 can include highdensity foam having a Shore A hardness between about 30 and about 50. Inother embodiments, the body 912 can include a high density foam having ahigher or lower Shore A hardness.

The body 912 extends proximally and distally of the pump assembly 908.The body 912 can be secured over the pump assembly 908 in any suitablemanner. For instance, the body 912 can be removably secured over thepump assembly 908 via an interference fit between the body 912 and thepump assembly 908. This allows the body 912 to be easily secured overthe pump assembly 908 as needed and easily removed. In otherembodiments, the body 912 can be secured over the pump assembly 908 viafasteners, hook-and-loop type systems, clips, magnets, adhesives or anyother suitable securing system. The body 912 can be attached to the atleast one strap 906. The body 912 can be directly attached to the dorsalshell 904.

The outer surface 920 of the body 912 can be continuous or interrupted.The outer surface 920 can provide a support area for the body 912 whenit is engaged with a support platform or other external object. It willbe appreciated that the body 912 can be oversized relative to the pumpassembly 908, helping to distribute forces through the body 912 awayfrom the pump assembly 908.

The inner surface 918 of the body 912 can be contoured to generallycorrespond to the contour of the anterior of the dorsal shell 904. Thiscan allow the body 912 to form a better fit between the protective part914 and the dorsal shell 904. The inner surface 918 can also provide asupport area for the body 912 against the dorsal shell 904 when theprotective part 914 is engaged with the dorsal shell 904.

As seen in FIG. 31, a cutout portion 924 is formed in the inner surface918 that extends between the side surfaces 922. The cutout portion 924can have a rectangular shape or any other shape arranged to accommodatea portion of the at least one strap 906, facilitating the securement ofthe body 912 over the pump assembly 908. The cutout portion 924 canterminate at upper and lower abutments 928. The cutout portion 924 cantaper in a direction toward the dorsal shell 904, allowing the upper andlower abutments 928 to engage with the inner surface of the upper andlower edges of the pump assembly 908 to secure to the body 912 over thepump assembly 908.

A receiving space or cavity 926 is defined in the cutout portion 924.The cavity 926 is arranged to accommodate at least part of the pumpassembly 908, allowing the control features of the pump assembly 908 tobe recessed within the body 912. Optionally, the cavity 926 can includea side opening for accommodating an inflation tube in fluidcommunication with the pump assembly.

The cutout portion 924 and/or the cavity 926 also facilitates alignmentof the body 912 with the pump assembly 908. For instance, the pumpassembly 908 and the inflation tube 910 can fit into the cavity 926 toensure the body 912 is properly positioned. When the body 912 is securedover the pump assembly 908, the pump assembly 908 is positioned withinthe cavity 926 and the body 912 keeps compressive forces exerted on thebody 912 away from the control features of the pump assembly 908.

In use, when a patient positions the anterior aspect of the dorsal shell904 on the support platform 903 of the knee scooter 901, the rigidity ofthe body 912 generally resists deformation and distributes the weight ofthe patient from the dorsal shell 904 through the body 912 away from thepump assembly 908 and to the support platform 903. The body 912 thusbeneficially protects the pump assembly 908 from damage and/orinadvertent operation when the walker 900 is used with a knee scooter,making the walker 900 safer and more versatile.

FIG. 32 shows another embodiment of a protective part 1012 forprotecting the pump assembly 908 from damage or inadvertent operation.The protective part 1012 comprises a wire structure 1014 extending overthe pump assembly 912. The wire structure 1014 includes a base frame1016 and a plurality of intersecting wire members 1020 defining openings1022 and extending over and across the pump assembly 908. The wiremembers 1020 collectively define a receiving space or cavity 1026 forreceiving or accommodating at least part of the pump assembly 908 whenthe wire structure 1014 is secured on the walker 900. The wire structure1014 can be made of metal, plastic, rubber, carbon, combinationsthereof, or any other suitable materials.

The wire structure 1014 has a rigidity arranged to distribute pressurefrom the patient or another external object away from the pump assembly908. The wire structure 1014 extends proximally and distally of the pumpassembly 908. The wire structure 1014 can be secured over the pumpassembly 908 in any suitable manner but is shown being secured over thepump assembly 908 by feeding or threading the at least one strap 906 andthe pump assembly 908 through at least two of the openings 1022 so thatthe base frame 1016 of the wire structure 1014 is secured between the atleast one strap 906 and the dorsal shell 904.

One or more access openings 1022A in the wire structure 1014 can besized and arranged so that a patient can manipulate the control featuresof the pump assembly 908 through the wire structure 1014 while it issecured over the pump assembly 908. This allows the wire structure 1014to both protect the pump assembly 908 from inadvertent operation andprovide operational access to the patient and/or clinician. While theprotective parts 914, 1012 are shown for use with the walker 900, itwill be appreciated that the exemplary embodiments of the protectivepart can be incorporated and/or used with a number of differentorthopedic devices.

FIG. 33 shows another embodiment of a protective part protective part814 for protecting the pump assembly 908 from damage or inadvertentoperation. The protective part 814 comprises a body 812 defining aninner surface arranged to engage and/or face the dorsal shell 904, anouter surface 820 opposite the inner surface, and side surfaces 822extending between the inner surface and the outer surface 820. The body812 can be formed of any of the materials previously described. Forinstance, the body 812 can be formed of a high density foam. The innersurface of the body 812 can be contoured to generally correspond to thecontour of the anterior of the dorsal shell 904. The inner surface ofthe body 812 can be permanently attached or integral to the anterior ofthe dorsal shell 904. The inner surface of the body 812 can be removablysecured to the anterior of the dorsal shell 904 under the at least onestrap 906.

The outer surface 820 of the body 812 can provide a support area for thebody 812 when it is engaged with a support platform or other externalobject. As seen, the body 812 can be oversized relative to the pumpassembly 908, helping to distribute forces through the body 812 awayfrom the pump assembly 908. A receiving space or cavity 826 is definedin the outer surface 820 for accommodating at least part of the pumpassembly 908. The cavity 826 is sized and configured such that the pumpassembly 908 can be generally recessed within the cavity 826 relative tothe outer surface 820 of the body 812. As such, the body 812 can bothprovide protection to the pump assembly 908 and allow a patient orclinician to manipulate the control features of the pump assembly 908while the protective part 814 is secured under the at least one strap906.

In an embodiment, the cavity 826 can extend completely through the sidesurfaces 822 of the body and can terminate at upper and lower abutments828, helping to facilitate alignment of the protective part 814 and thepump assembly 908. The cavity 826 can have any suitable shape but isshown to have a generally rectangular shape.

FIGS. 34-36 illustrate another embodiment of a protective part 1112 forprotecting a pump assembly on a walker 1100 from damage or inadvertentoperation. FIGS. 34-36 show a partial dorsal shell 1102 of the walker1100, which is removed from the base shell for ease of reference. Thedorsal shell 1102 can be formed either in a single piece or in multipleshell portions. In the exemplary embodiment, the dorsal shell 1102includes a proximal shell portion 1104 that is connected to a distalshell portion via a flexible or resilient portion or hinge connection1108.

The dorsal shell 1102 can include a reinforcing portion 1110 thatextends generally longitudinally along the dorsal shell 1102 toselectively strengthen the dorsal shell 1102. The reinforcing portion1110 can be formed in a single piece and from the same material as thedorsal shell 1102. In addition to adding structural support, thereinforcing portion 1110 can also enhance the low profile form of thewalker 1100. The reinforcing portion 1110 can further provide additionalsupport for engaging straps extending across the dorsal shell 1102.

The dorsal shell 1102 also includes a pump receiving opening 1116. Thepump receiving opening 1116 is shown formed in the reinforcing portionbut can be formed in any portion of the dorsal shell 1102. A pumpassembly comprising a flexible bulb type pump and push button releasevalve can be inserted through the pump receiving opening 1116.

The dorsal shell 1102 can include clearance holes 1114 defined therein.The clearance holes 1114 can be arranged in any suitable pattern. Forinstance, the clearance holes 1114 may be arranged at an oblique anglerelative to the reinforcing portion 1110 and may exhibit differentsizes. The clearance holes 1114 can reduce the weight of the walker1100. Further, the clearance holes 1114 can act as vents to allow heatand perspiration to pass from inside the walker 1100 to the exteriorthereof. Additionally, the clearance holes 1114 may also allow thedorsal shell 1102 to have some additional resiliency to accommodateswelling of a limb or users having different sizes of lower legs,ankles, and feet.

The protective part 1112 can be similar to the protective part 914except that the protective part 1112 is arranged to be selectivelysecured over a pump assembly extending through the pump receivingopening 1116 on the dorsal shell 1102. The protective part 1112comprises a semi-rigid or rigid body 1118 defining an inner surface 1120arranged to face the dorsal shell 1102, an outer surface 1122 oppositethe inner surface 1120, and side surfaces 1124 extending between theinner and outer surfaces 1120, 1122. The body 1118 can have an elongateconfiguration extending in a longitudinal direction along the dorsalshell 1102. The body 1118 can extend proximally and distally of the pumpassembly.

The outer surface 1122 can be continuous or interrupted. The innersurface 1120 can be contoured to generally correspond to the anterior ofthe dorsal shell 1102. This can allow the body 1118 to form a better fitbetween the body 1118 and the dorsal shell 1102. The inner surface 1120can also provide a support area for the body 1118 against the dorsalshell 1102 when the body 1118 is secured over a pump assembly extendingthrough the pump receiving opening 1116. The inner surface 1120 of thebody 1118 can engage the dorsal shell 1102 on opposing sides of thereinforcing portion 1110 which, in turn, helps the body 1118 todistribute forces away from a pump assembly.

The inner surface 1120 defines a cutout portion 1128 arranged to receivethe reinforcing portion 1110 of the dorsal shell 1102. This can helpalign the body 1118 with the pump assembly. For instance, thereinforcing portion 1110 can fit into the cutout portion 1128 to helpensure the pump assembly is properly positioned in the body 1118. Thecutout portion 1128 can also help lower the profile of the body 1118 onthe dorsal shell 1102.

A receiving space or cavity 1126 is defined in the cutout portion 1128.The cavity 1126 is arranged to receive or accommodate at least part ofthe pump assembly, allowing the pump assembly to be generally recessedwithin the body 1118.

Similar to the other embodiments, the body 1118 is securable over thepump assembly in any suitable manner and has a rigidity arranged todistribute pressure from the patient, walker, or another external objectaway from the pump assembly. The body 1118 can be removably secureddirectly to the dorsal shell 1102. For instance, the body 1118 can beremovably secured to the dorsal shell 1102 via hook-and-loop typesystems, magnets, adhesives, or fasteners. According to a variation, thebody 1118 can be secured to the dorsal shell 1102 via a snap-typeconnection. The body 1118 can include a plurality of snaps or hookmembers integrally formed on the inner surface 1120 and configured tosnap, lock or clip into one or more clearance holes 1114 formed in thedorsal shell 1102, facilitating assembly.

In other embodiments, the protective part can be permanently attached tothe dorsal shell. For instance, the protective part can be a structureor body that is permanently and pivotally attached to the dorsal shell.The body can be arranged to pivot away from the dorsal shell to provideaccess to the pump assembly and to pivot toward the dorsal shell toconceal and protect the pump assembly.

Another exemplary embodiment of an orthopedic device comprising a walker1200 is shown in FIGS. 37-41. Similar to the other embodiments, thewalker 1200 includes complementary base and dorsal shells 1202, 1204 anda plurality of straps 1206 arranged to bring the base shell 1202 and thedorsal shell 1204 closer together. This embodiment includes astabilizing part 1208 positioned on a posterior aspect of the base shell1202 that is arranged to support the walker 1200 against rotation (e.g.,external and/or internal rotation) when a patient has their footelevated or is resting the foot with the posterior aspect of the walker1200 on a resting surface 1201 such as a bed, the ground, an examinationtable, a couch, or any other applicable surface.

Conventional walkers typically have rounded posterior heel profiles(when viewed from the proximal aspect of the calf) based on the internalfeatures of the walker to accommodate the patient's rounded heelanatomy. This rounded posterior heel profile of the walker causes thewalker to be relatively unstable when the patient is elevating theirfoot and resting the walker on the posterior aspect of the walker. Inaddition, the walker tends to be fairly heavy as compared to the typicalweight of the patient's foot, which, in turn, tends to cause the walkerto roll or externally rotate when the walker is elevated. Furthermore,patients tend to rest with their feet externally rotated (e.g., toed-outto the lateral side) further exacerbating the instability of the walker.

The stabilizing part 1208 supports the walker 1200 against rotation whena patient is resting the foot without substantially affecting thefunctionality of the walker 1200 during gait. It also does so withoutthe use of complicated and bulky components. Furthermore, thestabilizing part 1208 can be a separate add-on component to the walkerand can be adapted to fit a number of different orthopedic devices,providing versatility.

The stabilizing part 1208 can be formed in a single piece and of thesame material as the base shell 1202. The stabilizing part 1208 can beformed of a semi-rigid or rigid material such as, for example, rigidplastic like polypropylene and/or a softer material such as foam.According to a variation, an elastomer can be overmolded or adhered tothe stabilizing part 1208 to provide a softer contact surface in theevent the stabilizing part 1208 contacts external objects. Thestabilizing part 1208 can be separate from or integral to the posteriorheel portion 1214 of the walker.

In an embodiment, the stabilizing part 1208 comprises an elongate body1210 arranged to be secured across the posterior heel portion 1214 ofthe base shell 1202. The body 1210 can wrap or extend around a portionof the lateral and/or medial side of the walker 1200.

The body 1210 defines an inner surface 1216, an outer surface 1218opposite the inner surface 1216, and side surfaces 1220 extendingbetween the outer and inner surfaces 1218, 1216. The inner surface 1216is arranged to engage the posterior heel portion 1214 and is contouredto generally correspond to the shape or curvature of the posterior heelportion 1214 of the walker 1200. This can allow the stabilizing part1208 to form a better fit between the body 1210 and the posterior heelportion 1214. The inner surface 1216 can also provide a support area forthe body 1210 against the base shell 1202 when a patient is resting thefoot with the posterior aspect of the walker 1200 on a resting surface.

As noted above, the stabilizing part 1208 has a low-profileconfiguration such that it generally does not disrupt a patient's gaitwhile it is secured to the posterior heel portion 1214. The body 1210can have a width that is between about 0.5 times and about 1 times(e.g., about 0.9 times), about 0.6 times and about 0.9 times, or about0.7 times and about 0.8 times a maximum width of the walker 1200. Inother embodiments, the body 1210 can have a greater or lesser width.

In an embodiment, the outer surface 1218 of the body 1210 can have awidth generally corresponding to the width of the posterior aspect ofthe walker 1200. The outer surface 1218 can have width between about 3inches and about 7 inches, about 3.5 inches and about 6.5 inches, orabout 4 inches and 6 inches. In other embodiments, the outer surface1218 can have a greater or lesser width.

As seen in FIGS. 39 and 40, the body 1210 extends along an axis Xbetween the side surfaces 1220. An axis Y extends along a height of thebody 1210 between the upper and lower edges so that the axis Yintersects the axis X. The body 1210 can define upper and lower cutouts1234, 1236. The cutouts 1234, 1236 reduce the weight of the stabilizingpart 1208 and improve the fit of the stabilizing part 1208 on theposterior heel portion 1214 of the walker 1200.

The stabilizing part 1208 includes at least one counter-rotation feature1240 arranged to support the walker 1200 against external and/orinternal rotation when a patient is resting the posterior aspect of thewalker 1200 on the resting surface. In the illustrated embodiment, theat least one counter-rotation feature defines a first point of rotation1242 about which the walker 1200 will have to overturn to externallyrotate and a second point of rotation 1246 about which the walker 1200will have to overturn to internally rotate. The first and second pointsof rotation 1242, 1246 are each offset a distance from a center of mass1248 of the walker 1200 along the axis X. The distances between thefirst and second rotation points 1242, 1246 and the center of mass 1248can be the same or different. At least one of the first point ofrotation 1242 and the second point of rotation 1246 can be offset adistance from the center of mass 1248 of greater than about 0.3 times,0.4 times 0.5 times, or about 0.6 times the width of the posterioraspect of the walker 1200.

If the posterior heel portion 1214 of the walker 1200 is resting on aresting surface and leans toward one side or the other, a driving momentis created that tends to rotate the walker 1200 about the first orsecond points of rotation 1242, 1246. Because the points of rotation arespaced a distance from the center of mass 1248 along the axis X, theweight of the walker 1200 can provide a counterforce that creates aresisting moment in the opposite direction about the first or secondpoints of rotation 1242, 1246. This resisting moment can resist rotationof the walker 1200 about the points of rotation 1242, 1246, stabilizingthe walker 1200 on the resting surface.

When the posterior heel portion 1214 of the walker 1200 is resting on aresting surface and the walker 1200 tends to externally rotate about thefirst point of rotation 1242 of the counter-rotation feature 1240 on theresting surface, the weight of the walker 1200 can provide a counterforce that creates a resisting moment in the opposite direction aboutthe first point of rotation 1242, supporting the walker 1200 againstsuch external rotation.

When the posterior heel portion 1214 of the walker 1200 is resting on aresting surface and the walker 1200 tends to internally rotate about thesecond point of rotation 1246 of the counter-rotation feature 1240 onthe resting surface, the weight of the walker 1200 can provide counterforce that creates a resisting moment in the opposite direction aboutthe second point of rotation 1246, supporting the walker 1200 againstsuch internal rotation.

The stabilizing part 1208 can thus stabilize the walker 1200 againstboth internal and external rotation when the patient is resting the footwith the posterior aspect of the walker 1200 on a resting surface. Itwill be appreciated that when the walker 1200 with the stabilizing part1208 is placed on a softer resting surface, the stabilizing part 1208can partially sink or be absorbed into the softer resting surface toallow or accommodate some degree of external rotation of the walker1200. For instance, the stabilizing part 1208 can sink and partiallyrotate on the resting surface to accommodate between about 5 and about 7degrees external rotation of the walker 1200.

As seen FIG. 39, the at least one counter-rotation feature 1240 is aportion of the outer surface 1218 being generally flat or level in atransverse direction along the axis X. The flat or level of the outerportion 1218 can extend between the side surfaces 1220A, 1220B.

It will be appreciated that other counter-rotation features arepossible. For instance, the at least one counter-rotation feature caninclude the outer surface 1218 being concave across the width of theouter surface 1218. In other embodiments, the at least onecounter-rotation feature can include posteriorly extending lateral andmedial support arms on the outer surface 1218 defining first and secondrotation points, each offset a distance from a center of mass 1248 ofthe walker 1200 along the axis X.

While two points of rotation are described, it will be appreciatedthree, four, or any other suitable number of points of rotation arepossible. For instance, the at least one counter-rotation feature candefine a lateral point of rotation spaced from the center of mass 1248but not a medial point of rotation so that the stabilizing part 1208only substantially supports the walker 1200 against external rotation.

In other embodiments, one of the points of rotation can be closer to thecenter of mass than the other so that the stabilizing part 1208 providesmore support against rotation along the axis X in one direction thananother direction. In addition, while the stabilizing part is describedfor use on a walker, in other embodiments, the stabilizing part can bearranged for use with a cast, a therapeutic boot, or any other suitableorthopedic device.

According to a variation, the side surface 1220A can define a generallyflat surface extending substantially normal to the outer surface 1218.Opposite the side surface 1220A, the side surface 1220B can define aninclined surface 1224 extending between the inner and outer surfaces andarranged to extend along the medial side of the walker 1200. Theinclined surface 1224 advantageously lowers the profile of thestabilizing part 1208 along the medial side, helping to reduce thelikelihood of the stabilizing part 1208 catching or bumping against theunaffected leg during gait. The inclined surface 1224 also can enhancethe flexibility of the body 1210 at or near the side surface 1220B,facilitating attachment of the stabilizing part 1208 to the walker 1200.

The stabilizing part 1208 can also be configured so that it can be usedon the left foot or the right foot. For instance, FIG. 40 illustratesthe body 1210 being substantially symmetric about the axis X. Thisadvantageously allows the same stabilizing part 1208 to be used on theleft or right foot by simply turning the body 1210 over and attaching itto the walker 1200. Such a configuration can allow a patient to positionthe inclined surface 1224 along the medial side of the walker 1200 oneither the right or left foot as needed. Optionally, the stabilizingpart 1208 includes visual indicators 1226 to clarify which orientationof the body 1210 is to be used for which foot. The visual indicators1226 may include an “R” for right and an “L” for left.

The stabilizing part 1208 can be secured to the posterior heel portion1214 of the walker 1200 in any suitable manner. For instance, the body1210 can include an attachment system 1230 for securing the stabilizingpart 1208 on the posterior heel portion 1214. The attachment system 1230can include hook members 1232 defined by the body 1210 arranged toselectively clip or lock in one or more attachment holes 1238 (shown inFIG. 38) defined on the base shell 1202. The hook members 1232 can beconfigured to engage an interior surface of the base shell 1202 when thebody 1210 is secured on the posterior heel portion 1214. In otherembodiments, the attachment system 1230 can comprise hook-and-loopsystems, snaps, fasteners, or any other suitable system.

As seen in FIG. 41, the outer surface 1218 can also be contoured in avertical direction (e.g., about the axis X or generally between theupper and lower edges). For instance, the outer surface 1218 of the body1210 can curve in the vertical direction along the axis Y upward (e.g.,away from the inner surface) from the lower edge through an apex 1228,and then downward to the upper edge. The radius of the curvature of theouter surface 1218 along the axis Y can be constant or can vary. Thus,the outer surface 1218 along the axis Y can be convexly curved. Thisadvantageously reduces the likelihood of the stabilizing part 1208 fromcatching during use, or more specifically when descending stairs. Thisalso advantageously allows the walker 1200 to be titled or slightlypivoted with respect to the resting surface, such that the body 1210still supports the position of the patient's foot even when theposterior of the walker 1200 is not completely parallel to the restingsurface. In other embodiments, the outer surface 1218 can be contouredin the vertical direction such that the body 1210 has a faceted,trapezoidal, or other cross-section shape.

Another exemplary embodiment of a stabilizing part 1308 is shown in FIG.42. The stabilizing part 1308 comprises an outer member 1314 having arigid or semi-rigid configuration and an inner member 1316. The outermember 1314 can include a pair of side members 1318 arranged to extendalong a portion of the lateral and medial sides of a walker and a centerportion 1320 extending between the side members 1318. The center portion1320 can include at least one counter-rotation feature comprising acentral channel 1322 in the outer surface and supports 1340 on oppositesides of the central channel 1322.

The supports 1340 define a first point of rotation 1342 about which awalker will have to overturn to externally rotate and a second point ofrotation 1344 about which the walker will have to overturn to internallyrotate. The first and second points of rotation 1342, 1344 are eachoffset a distance from a center of mass 1348 of a walker along an axisX1. As such, if the posterior aspect of the walker is resting on aresting surface and leans toward one side or the other, a driving momentis created that tends to rotate the walker about the first or secondpoints of rotation 1342, 1344. Because the points of rotation 1342, 1344are spaced a distance from the center of mass 1348 along the axis X1,the weight of the walker on the stabilizing part 1308 can create aresisting moment in the opposite direction about the first or secondpoints of rotation 1342, 1344 that tends to resist rotation of thewalker about the points of rotation 1342, 1344, stabilizing the walkeron the resting surface.

The inner member 1316 can be attached to the outer member 1314 anddefine an inner surface 1324 arranged to engage the posterior heelportion of the walker. The inner surface 1324 extends across theposterior of the walker and along a portion of the lateral and medialsides of the walker. According to a variation, the inner member 1316 canbe formed of a softer material arranged to conform to the shape of thewalker, allowing the stabilizing part 1308 to fit walkers of differentshapes.

The stabilizing part 1308 can be attached to the walker in any suitablemanner but is shown being removably attachable to a walker via ahook-and-loop type system 1326. In other embodiments, the stabilizingpart 1308 can be attached to the walker via clips, fasteners, magnets,adhesives, or any other suitable attachment system.

As noted above, embodiments of the orthopedic system can be adapted foruse with other components. FIGS. 43-45 illustrate another embodimentincluding an activity tracking device integrated into an orthopedicdevice comprising a walker. This beneficially allows a clinician tomonitor a patient's activity levels and/or compliance by identifyingboth patients who may be too active as well as those who may be inactive(potentially indicating a lack of compliance with clinicianinstructions).

Conventional walkers do not integrate a means of remotely monitoringpatient activity level or compliance with physician instructions. Thiscan lead to negative patient outcomes with unknown or difficult todiagnose causes. For instance, a very active patient may be running orjogging with sprains or fractures of the lower leg, increasing stress onan injury and delaying healing. Alternatively, a patient may be removinga walker which is required for a specific treatment, such as in the caseof diabetic ulcer healing, where lack of compliance is believed to be acommon cause of increased diabetic ulcer healing time.

In the illustrated embodiment, an activity tracking device 1402 is addedto or integrated with a walker 1400 and linked or registered within asoftware application or remote patient monitoring system. The activitytracking device 1402 can generate information associated with thepatient's level of activity or compliance during treatment. A cliniciancan then access and use the data or information collected by theactivity tracking device 1402. The clinician can have continuous orintermittent access to the data or information collected by the activitytracking device 1402. For instance, the clinician may only be able toaccess the data or information from the activity tracking device 1402during an office visit or during a specific period of time. In otherembodiments, the clinician may be able to access the information or dataon demand or at any time.

The clinician can use the data or information for determining complianceand/or monitoring the patient's activity level. A clinician can also usesuch information for troubleshooting potential treatment issues and/orto identify other treatment options for the patient. This advantageouslyoffers an improvement over prior art walkers, which are unable to trackand report on a patient's activity during therapy. While the orthopedicdevice is described as a walker, it will be appreciated that in otherembodiments the orthopedic device can be a therapeutic shoe, a totalcontact cast, or any other suitable orthopedic device.

The activity tracking device 1402 can be any suitable device. Theactivity tracking device 1402 can include one or more sensors such as athree-dimensional accelerometer to sense patient movement. The activitytracking device 1402 can measure steps taken and combine this data withindividual patient characteristics to calculate distance walked,calories burned, floors climbed, activity duration, and/or activityintensity. The activity tracking device 1402 can measure periods ofinactivity. In other embodiments, the one or more sensors may includepressure sensors, force sensors, and/or temperature sensors.

The activity tracking device 1402 can include a control system toreceive and/or process information from the one or more sensors and/orconnect, and transmit information to a computer device or system asdescribed below. The activity tracking device 1402 can be a sealed orwaterproof unit and/or have a long battery life (e.g., greater thanabout 3 months), enhancing the usability of the system, as walkers tendto get wet during use and some patients visit their cliniciansinfrequently, creating a lengthy time between opportunities forcharging.

The activity tracking device 1402 can be integrated in the walker 1400in a variety of different ways. For example, the activity trackingdevice 1402 is positioned under a cover member 1404 attached to theposterior aspect of a base shell 1406 of the walker 1400. Placement ofthe activity tracking device 1402 on the posterior aspect of the walker1400 reduces the likelihood of patient tampering or interference as theactivity tracking device 1402 is out of the patient's sight and is moredifficult to access during use.

In an embodiment, the cover member 1404 can be a removable andreplaceable component of the walker 1400. For instance, the cover member1404 can be sized and configured to be interchangeable with embodimentsof the air system cover previously described. As such, the cover member1404 and activity tracking device 1402 can be an add-on module oraccessory sold separately from the walker 1400.

As seen in FIGS. 43 and 44, the cover member 1404 can be attached to thebase shell 1406 over a cutout 1408 formed in the walker 1400. The covermember 1404 includes a base portion 1410 and a peripheral sidewall 1412extending from the base portion 1410 toward the base shell 1406 of thewalker 1400.

As shown in FIG. 45, a receiving space 1414 in the cover member 1404 isbounded by the sidewall 1412 and the base portion 1410 so that thebottom of the receiving space 1414 is recessed within the sidewall 1412to provide a space for the activity tracking device 1402. This can allowthe base portion 1410 and the sidewall 1412 to substantially enclose theactivity tracking device 1402 within the receiving space 1414,protecting the activity tracking device 1402 and helping to detertampering. The cover member 1404 also helps reduce the likelihood of theactivity tracking device 1402 being accidentally dislodged during use.The activity tracking device 1402 can be secured in the receiving space1414 via a hook member 1422 defined on the inner surface of the covermember 1404. The activity tracking device 1402 can be secured in thereceiving space 1414 via an interference fit between the cover member1404 and the activity tracking device 1402. The activity tracking device1402 can be secured in the receiving space 1414 via adhesives, a snapfit, or any other suitable manner.

The sidewall 1412 defines a rim 1416 extending around the base portion1410. At least a portion of the rim 1416 can be contoured to generallycorrespond to the contour or shape of the posterior of the base shell1406. This can allow the cover member 1404 to form a better fit betweenthe cover member 1404 and the base shell 1406. The rim 1416 can alsoprovide a support area for the cover member 1404 when the cover member1404 is attached to the base shell 1406.

The cover member 1404 can be attached to the base shell 1406 in anysuitable manner. The cover member 1404 can be secured to the base shell1406 via a snap-type connection. The cover member 1404 includes aplurality of snaps or hook members 1420 integrally formed on thesidewall 1412 and configured to snap into the cutout 1408 formed in thebase shell 1406, facilitating attachment. Alternatively, the covermember 1404 can be removably attached to the base shell 1406 viafasteners, hook-and-loop type systems, clips, magnets, or any othersuitable attachment system.

According to another embodiment, the cover member 1404 can beirreversibly attachable to the walker 1400. To protect the activitytracking device 1402 and prevent tampering, the cover member 1404 can besecurely attached to the walker 1400 via gluing, plastic welding, or anyother suitable manner such that it cannot be removed by the patientwithout breaking the cover member 1404, which would provide a visibleindication of unauthorized tampering with the activity tracking device1402.

As noted above, the activity tracking device 1402 can be linked with asoftware application or patient monitoring system. For instance, theactivity tracking device 1402 can be operatively coupled to a monitoringsystem 1500 including a computer device 1505 as seen in FIG. 46. Thecomputer device 1505 can display information to a patient or clinicianand receive input, respectively. For instance, a clinician or patientcan input patient characteristics data via the computer device 1505,which, in turn can be processed by the activity tracking device 1402and/or the computer device 1505 with the step information from theactivity tracking device 1402 to calculate activity information such as,but not limited to, distance walked, activity duration, and/or activityintensity. As seen, the computer device 1505 can be a mobile device. Amobile device is a processing device routinely carried by a user. Ittypically has a display screen with touch input and/or a keyboard, andits own power source. As such, the computer device 1505 can provide apatient or clinician the freedom to use it almost anywhere. The computerdevice 1505 can be a hand-held device. The computer device 1505 can be atablet computer, a smartphone, a laptop, a mobile telephone, a PDA, orother appropriate device.

The computer device 1505 can be communicatively coupled to the activitytracking device 1402. The computer device 1505 can be communicativelycoupled to the activity tracking device 1402 via a secure or unsecurewireless connection.

The computer device 1505 can be communicatively coupled to a server orcomputer system 1501 over a network 1503, such as for example, a LocalArea Network (“LAN”), a Wide Area Network (“WAN”), or the internet. Thecomputer system 1501 can be used for controlling/monitoring the computerdevice 1505 and/or the activity tracking device 1402. In an embodiment,the computer system 1501 can provide a patient feedback by directing theactivity tracking device 1402 to vibrate a vibrator of the activitytracking device 1402 if step or activity information generated by theactivity tracking device 1402 and/or the computer device 1505 exceeds avalue limit.

The computer system 1501 can be used for exchanging data/files with thecomputer device 1505 and/or the activity tracking device 1402. Forinstance, the activity tracking device 1402 can send one or more filesincluding step information and/or activity information to the computerdevice 1505 and/or the computer system 1501. It will be appreciated thatthe computer device 1505 can be separate from or integral to thecomputer system 1501.

This allows a clinician to ascertain the patient's level of activity orcompliance during treatment by accessing the information generated bythe activity tracking device 1402 remotely via the computer device 1505and/or the computer system 1501. For instance, the computer device 1505can provide a clinician feedback if step or activity informationgenerated by the activity tracking device 1402 exceeds or fails toexceed a value limit stored in the computer device 1505 or computersystem 1501. The value limit can be based on patient characteristics,treatment protocols, and/or physician instructions. The value limit canbe time dependent. In an embodiment, the computer device 1505 canprovide a clinician feedback if step information generated by theactivity tracking device 1402 indicates that the patient has not taken astep within a specified time period (e.g., a 24-hour period). Theclinician can then use such feedback to make a determination ofnon-compliance.

According to a variation, the clinician may setup the activity trackingdevice 1402 within the system 1500 via a registration link or programthat limits connection to the activity tracking device 1402 to a singleuser, reducing the likelihood of unauthorized access to the activitytracking device 1402 and helping to maintain patient confidentiality.

The system 1500 thus gives a clinician freedom to monitor the patient'sactivity level and/or compliance from almost anywhere and at any timewithout having to have physical access to the activity tracking device1402. For instance, the clinician can access the activity trackingdevice 1402 wirelessly via the computer device 1505 or the computersystem 1501 during office visits or routine check-ups. Informationgenerated by the system 1500 can then be used by the clinician fortroubleshooting potential treatment issues or to identify other coursesof treatment for the patient. According to a variation, the activitytracking device 1402 can be accessed physically by a clinician.

The exact division of labor between the computer system 1501, theactivity tracking device 1402, and the computer device 1505 may vary.For instance, the computer device 1505 can receive and store data/filesfrom the activity tracking device 1402, and the activity tracking device1402 can perform all other operations. In other embodiments, theactivity tracking device 1402 can transmit data to the computer device1505 and/or computer system 1501 and the computer device 1505 and/orcomputer system 1501 processes, stores, and displays information to theclinician. Any division of labor between the activity tracking device1402, the computer device 1505, and the computer system 1501 is alsowithin the scope of the present disclosure.

In other embodiments, the walker can be modified, providing a receptacleto receive and secure embodiments of the activity tracking device. FIG.47 illustrates another embodiment of a walker 1600 defining a receptacle1602 having a receiving space arranged to receive and secure an activitytracking device 1604 in the receptacle 1602. This can allow for theactivity tracking device 1604 to be sold as a stand-alone accessory orwith the walker 1600 as a package. As seen, the receptacle 1602 can bepositioned on a side of a base shell 1606 of the walker 1600. Thispermits the activity tracking device 1604 to be located on the lateralside of the walker 1600, which, in turn, helps prevent the activitytracking device 1604 from interfering with the patient's gait.

According to a variation, the activity tracking device can be integratedwith the dorsal shell. For instance, FIG. 48 shows another embodiment ofa walker 1700 including a dorsal shell 1702 defining a receptacle 1704having a receiving space arranged to receive an activity tracking device1706. It will be appreciated that the receptacle 1704 can be formed onthe inner or outer surfaces of the dorsal shell 1702 and/or in theproximal shell section or the distal shell section. Integrating theactivity tracking device 1706 on the dorsal shell may enhance theaccuracy of data generated by the activity tracking device 1706 becausethe movement of the activity tracking device on the dorsal shell maymore closely track the actual movement of the patient's foot and/orlower leg.

In yet other embodiments, the activity tracking device can be secured toa strap member of the walker, making the activity tracking device easyto attach and access for a clinician. In other embodiments, the activitytracking device can be integrated into an insole, outsole, or any othersuitable portion of an orthopedic device.

While various aspects and embodiments have been disclosed herein, otheraspects and embodiments are contemplated. The various aspects andembodiments disclosed herein are for purposes of illustration and arenot intended to be limiting. Additionally, the words “including,”“having,” and variants thereof (e.g., “includes” and “has”) as usedherein, including the claims, shall be open-ended and have the samemeaning as the word “comprising” and variants thereof (e.g., “comprise”and “comprises”).

1. An orthopedic system comprising: an orthopedic device defining aposterior aspect, an anterior aspect opposite the posterior aspect, anda structure at least in part defining a receiving space arranged toreceive an activity tracking device; and an activity tracking devicepositionable and securable in the receiving space of the orthopedicdevice, the activity tracking device arranged to generate informationassociated with activity level or compliance of a patient wearing theorthopedic device.
 2. The orthopedic system of claim 1, wherein theorthopedic device includes a cover member attachable to the posterioraspect of the orthopedic device, and the receiving space is locatedunder the cover member.
 3. The orthopedic system of claim 2, wherein thecover member is irreversibly attachable to the posterior aspect of theorthopedic device.
 4. The orthopedic system of claim 2, wherein thecover member is removably attachable to the posterior aspect of theorthopedic device.
 5. The orthopedic system of claim 2, wherein thecover member has a rigid configuration and substantially encloses theactivity tracking device.
 6. The orthopedic system of claim 2, whereinthe cover member includes a plurality of hook members configured to snapinto a cutout formed in the posterior aspect of the orthopedic device.7. The orthopedic system of claim 2, wherein the cover member includes abase portion and a peripheral sidewall extending from the base portiontoward the posterior aspect of the orthopedic device, the base portionand the sidewall substantially enclosing the activity tracking device.8. The orthopedic system of claim 6, wherein the activity trackingdevice is securable within the receiving space via a hook member definedon an inner surface of the cover member.
 9. The orthopedic system ofclaim 1, wherein the receiving space is located within a receptacledefined on a lateral side of the orthopedic device.
 10. The orthopedicsystem of claim 1, wherein the receiving space is located within areceptacle defined on a dorsal shell of the orthopedic device.
 11. Theorthopedic system of claim 1, wherein the generated information from theactivity tracking device is accessible by a clinician via a monitoringsystem operatively coupled to the activity tracking device.
 12. Theorthopedic system of claim 11, wherein the monitoring system includes acomputer device communicatively coupled to the activity tracking devicevia a secure wireless connection.
 13. The orthopedic system of claim 11,wherein the monitoring system is arranged to provide the clinicianfeedback if the generated information from the activity tracking deviceis above or below a value limit.
 14. The orthopedic system of claim 13,wherein the generated information includes at least one of stepinformation and activity information.
 15. The orthopedic system of claim11, wherein the monitoring system is arranged to provide feedback to thepatient if the generated information from the activity tracking deviceis above or below a value limit.
 16. An orthopedic system comprising: anorthopedic device having ankle and foot receiving portions, and defininga posterior aspect and an anterior aspect opposite the posterior aspect;a cover member removably securable to the posterior aspect of theorthopedic device, the cover member having a rigid configuration anddefining a receiving space; and an activity tracking device securable inthe receiving space and arranged to generate information associated withactivity level or compliance of a patient wearing the orthopedic deviceduring treatment.
 17. The orthopedic system of claim 16, wherein thecover member includes a base portion and a peripheral sidewall extendingfrom the base portion toward the posterior aspect of the orthopedicdevice, the base portion and the sidewall substantially enclosing theactivity tracking device.
 18. The orthopedic system of claim 16, whereinthe activity tracking device is secured within the receiving space viaan interference fit between the cover member and the activity trackingdevice.
 19. The orthopedic system of claim 16, wherein the cover isformed of a same material as the posterior aspect of the orthopedicdevice.
 20. An orthopedic system comprising: a walker including a baseshell forming an opening and a dorsal shell contoured to generallycorrespond to the opening of the base shell; a cover member irreversiblysecurable to a posterior aspect of the base shell, the cover memberhaving a rigid configuration and defining a receiving space; and anactivity tracking device securable in the receiving space and arrangedto generate information associated with activity level or compliance ofa patient wearing the walker during treatment.